Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58
Fresenius Kabi Compounding
💊 Drugs Class I - Dangerous
cGMP violations
All Recalls
92,900 total recalls in our database
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58
Fresenius Kabi Compounding
💊 Drugs Class I - Dangerous
CGMP violations
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58
Fresenius Kabi Compounding
💊 Drugs Class I - Dangerous
cGMP violations
Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C; b) MAJOR GYNE LAPAROSCOPY SHSC, REF DYNJ46774B; c) GYN ANCILARY PACK, REF DYNJ84509; d) GYN LITHOTOMY MINOR, REF DYNJ907707
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
🏥 Medical Devices Class I - Dangerous
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.
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.
SynchroMed II Infusion Pump. Product Number: 8637-20
Medtronic Neuromodulation
🏥 Medical Devices Class I - Dangerous
Potential for error and inability to interrogate pump due to data corruption in the pump memory.
Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure convenience kit
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
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 Arterial Kit 1/EA, Product Code REF MX7827
Smiths Medical ASD
🏥 Medical Devices Class I - Dangerous
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.
smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714
Smiths Medical ASD
🏥 Medical Devices Class I - Dangerous
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 DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT
Smiths Medical ASD
🏥 Medical Devices Class I - Dangerous
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 DENTAL PACK, REF DYNJ64086B; medical procedure convenience kit
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
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, 100mL, FS, Product Code 21-7302-24JP
Smiths Medical ASD
🏥 Medical Devices Class I - Dangerous
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.
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.
🏥 Medical Devices Class I - Dangerous
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
🏥 Medical Devices Class I - Dangerous
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
Centurion OB TRAY, REF MNS13965A; medical procedure convenience kit
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
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.
smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
Smiths Medical ASD
🏥 Medical Devices Class I - Dangerous
Uncertainty in the seal integrity of the sterile packaging.