Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.
Cardinal Health 200
274 recalls • • Categories: Infusion Pumps, Other Medical Devices, Implants & Prosthetics, Surgical Instruments, Patient Monitors +1 more
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Class I - Dangerous
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Class I - Dangerous
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Class I - Dangerous
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Class I - Dangerous
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Class I - Dangerous
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Class I - Dangerous
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Class I - Dangerous
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Class I - Dangerous
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class I - Dangerous
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class I - Dangerous
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class I - Dangerous
Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection requirements.
Class I - Dangerous
Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection requirements.
Class I - Dangerous
Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility with needleless Intravenous (IV) connectors. Cardinal Health recommends that they not be used for administration of IV push insulin via needleless connector.
The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.
Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.
Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.
Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.
Class I - Dangerous
Potential contamination of the product with latex adhesive residual.
Class I - Dangerous
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
Class I - Dangerous
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
Class I - Dangerous
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
Class I - Dangerous
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
Class I - Dangerous
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
Dover" IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PROTECTOR, ALCOHOL, LIDDED
Class I - Dangerous
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Class I - Dangerous
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD
Class I - Dangerous
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Class I - Dangerous
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.
Class I - Dangerous
The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.
Class I - Dangerous
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.
Class I - Dangerous
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.
Class I - Dangerous
The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.
Class I - Dangerous
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.
Class I - Dangerous
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.
Class I - Dangerous
The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.
Class I - Dangerous
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.
Class I - Dangerous
The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.
Class I - Dangerous
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.
Class I - Dangerous
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.
Class I - Dangerous
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.
Class I - Dangerous
The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.
Class I - Dangerous
The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.
Class I - Dangerous
The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.
Class I - Dangerous
Demonstrated recognition and compatibility issues with syringe infusion pumps.
Class I - Dangerous
Demonstrated recognition and compatibility issues with syringe infusion pumps.
Class I - Dangerous
Demonstrated recognition and compatibility issues with syringe infusion pumps.
Class I - Dangerous
Demonstrated recognition and compatibility issues with syringe infusion pumps.
Class I - Dangerous
Demonstrated recognition and compatibility issues with syringe infusion pumps.
Class I - Dangerous
Demonstrated recognition and compatibility issues with syringe infusion pumps.
Class I - Dangerous
Syringe contains conical tip that is not compatible with certain needleless IV connector(s).
Class I - Dangerous
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
Class I - Dangerous
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
Class I - Dangerous
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
XXX
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
Class I - Dangerous
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
Class I - Dangerous
Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regarding the above listed lot of the Novalplus Infant Heel Warmer with tape.
Class I - Dangerous
Inadvertently released for distibution without sterility assurance.
Class I - Dangerous
Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss of fluid path integrity
Class I - Dangerous
Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss of fluid path integrity