💊 Drugs Class I - Dangerous
CGMP DEVIATIONS
All Recalls
95,018 total recalls in our database
Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-148-94
Denver Solutions, LLC
💊 Drugs Class I - Dangerous
CGMP DEVIATIONS
💊 Drugs Class I - Dangerous
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
💊 Drugs Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date
💊 Drugs Class I - Dangerous
CGMP DEVIATIONS
Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-493-01; NDC Unit Dose: 60687-493-11.
Amerisource Health Services
💊 Drugs Class I - Dangerous
Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
🏥 Medical Devices Class I - Dangerous
When the user pauses the beam delivery, the dose timer is reset (to zero), and as a result may deliver an unexpected dose to the patient.
🏥 Medical Devices Class I - Dangerous
Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately 2,000 ft. (610 meters) above sea level; operation outside of the intended radiofrequency has the potential to result in inaccurate readings or sensor signal acquisition difficulties.
🏥 Medical Devices Class I - Dangerous
There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart. In instance of helium regulator failure, a Pump Console s internal reservoir of helium will not be replenished when docked into an impacted Hospital Cart. This may result in an insufficient amount of helium within the internal reservoir.
🏥 Medical Devices Class I - Dangerous
Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately 2,000 ft. (610 meters) above sea level; operation outside of the intended radiofrequency has the potential to result in inaccurate readings or sensor signal acquisition difficulties.
🏥 Medical Devices Class I - Dangerous
Product is labeled with an incorrect expiration date.
🏥 Medical Devices Class I - Dangerous
Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted.
Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor
HeartSine Technologies
🏥 Medical Devices Class I - Dangerous
Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy.
🏥 Medical Devices Class I - Dangerous
Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted.
🏥 Medical Devices Class I - Dangerous
An unexpected shutdown of the IABP may occur due to loss of communication between the Executive Processor PCBA and the Video Generator PCBA. This may result in an interruption to therapy which may threaten the hemodynamic stability of the supported patient as the user is left unaware to the status of the Cardiosave IABP.
🏥 Medical Devices Class I - Dangerous
Users received sample collection kits that were assigned to another user. Incorrect shipping labels were applied to the collection kits. As a result, a number of users received sample collection kits that were assigned to another user resulting in a mismatch of user identification. The impact to users is that they may return the sample and obtain potential incorrect Hepatitis C Virus (HCV) results and/or the sample may be rejected due to mismatched demographics resulting in delayed testing and/or treatment.
🏥 Medical Devices Class I - Dangerous
Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.
Sprint 200 wheeled stretcher, Item numbers 1ES200-7, 1ES210-1, and 1ES211-1.
Linet Spol. S.r.o.
🏥 Medical Devices Class I - Dangerous
Labeling being updated to assure user is securing the siderail to a locked position to prevent potential patient fall and injury.
🏥 Medical Devices Class I - Dangerous
Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately 2,000 ft. (610 meters) above sea level; operation outside of the intended radiofrequency has the potential to result in inaccurate readings or sensor signal acquisition difficulties.
🏥 Medical Devices Class I - Dangerous
Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and tissue hang-up. These conditions may be associated to a delay to treatment, unspecified infection, hemorrhage/blood loss/bleeding, failure to anastomose, peritonitis, sepsis, pneumothorax, tissue trauma, or death.