ARROW PICC Set; Product codes: PR-35563-HPHNL and PR-35563-HPHNM
Arrow International
Class I - Dangerous
Product sterility may be compromised due to unsealed packaging.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Class I - Dangerous
Product sterility may be compromised due to unsealed packaging.
Respire Pink+ Hard/Soft Oral Sleep Apnea Device
Respire Medical
Class I - Dangerous
Potential for device breakage during use
0.2 Micron Flat Epidural Filter; Product Code: EF-05500
Arrow International
Class I - Dangerous
Product sterility may be compromised due to unsealed packaging.
Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.
NordicNeuroLab AS
Class I - Dangerous
An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or anterior-posterior flipping of images.
Maximal Barrier Drape; Product Codes: ASK-00376-SU
Arrow International
Class I - Dangerous
Product sterility may be compromised due to unsealed packaging.
Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.
Genesee BioMedical
Class I - Dangerous
Failure in a retractor blade due to corrosion. In the area of the blade where the bearing/button meets the blade body, corrosion can form, weakening the welded joint and may cause the bearing/button to break.
VPS TipTracker Stylet Accessory; Product codes: RHY-177-TTSAP
Arrow International
Class I - Dangerous
Product sterility may be compromised due to unsealed packaging.
Respire Pink+ Hard Oral Sleep Apnea Device
Respire Medical
Class I - Dangerous
Potential for device breakage during use
Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattresses. For the identified serial number range of P.R.O. Matt and ProCair Mattresses incorrect connectors (part #s 206-0401 & 206-0405) were provided by a Joerns supplier without the required internal shutoff valves, these shutoff valves prevent air from escaping from the mattress air cells.
Class I - Dangerous
Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattresses. For the identified serial number range of P.R.O. Matt and ProCair Mattresses incorrect connectors (part #s 206-0401 & 206-0405) were provided by a Joerns supplier without the required internal shutoff valves, these shutoff valves prevent air from escaping from the mattress air cells.
Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1
Arrow International
Class I - Dangerous
Product sterility may be compromised due to unsealed packaging.
Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
Maximal Barrier Drape; Product Code: ASK-01000-UPMS
Arrow International
Class I - Dangerous
Product sterility may be compromised due to unsealed packaging.
Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode may result in a Voltage Out of Range malfunction alarm, which causes the device to enter a safe state and become inoperable until it is serviced. Baxter will be releasing new firmware that will prevent the malfunction from occurring.
Class I - Dangerous
Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,
Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode may result in a Voltage Out of Range malfunction alarm, which causes the device to enter a safe state and become inoperable until it is serviced. Baxter will be releasing new firmware that will prevent the malfunction from occurring.
Class I - Dangerous
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode may result in a Voltage Out of Range malfunction alarm, which causes the device to enter a safe state and become inoperable until it is serviced. Baxter will be releasing new firmware that will prevent the malfunction from occurring.