It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
All Recalls
95,114 total recalls in our database
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
medex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530T
Smiths Medical ASD
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24
Smiths Medical ASD
Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
Medline brand medical procedure convenience kits, labeled as: a) NEURO PACK, REF DYNJ37909A; b) SHUNT PACK, REF DYNJ40040C
MEDLINE INDUSTRIES, LP - Northfield
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP
Smiths Medical ASD
Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740
Smiths Medical ASD
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
Medline PEDIATRIC DRAPE PK, REF DYNJ81297; medical procedure convenience kit
MEDLINE INDUSTRIES, LP - Northfield
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm, catherization table, image processing equipment, x-ray high voltage generator, x-ray tube. There are several types of each component.
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
If digital angiography system is used with a specific catheterization table and the operator directs simultaneous movement of the table and the C-arm using direct memory, then direct memory button is released, the table may continue to move, which the operator can stop by pressing the stop button.
The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086
Smiths Medical ASD
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Due to labeling issue. The box label is different that the gallon label in that gallon label shows a lower Calcium concentration than the box label.
medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543
Smiths Medical ASD
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
medex TranStar Disposable Transducer 1/EA, Product Code REF MX950
Smiths Medical ASD
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended as a control for urinalysis reagent strips, microalbumin, and creatinine by listed test methods.
Mckesson Medical-Surgical Inc. Corporate Office
The Quantimetrix Dipper Urinalysis Dipstick control was shipped without the validated summer packaging and may have been exposed to temperatures above 25¿C. This may lead to delay in patients' results.
Medline CV ANESTHESIA - ROOM SET UP, REF DYNJ905503F; medical procedure convenience kit
MEDLINE INDUSTRIES, LP - Northfield
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue Model/Catalog Number: TFL-SLS
Olympus Corporation of the Americas
The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.
smiths medical portex, 15mm Double Swivel Connector: a) REF 100/255/150; b) REF 100/255/150JP; c) REF 100/255/150 JS
Smiths Medical ASD
Uncertainty in the seal integrity of the sterile packaging.