Alerts

Altaire issued the retail level recall over quality concerns at their manufacturing facility.

Recall of Giraffe infant warmers and Panda i-Res infant warmers by GE Healthcare due to bedside panels and latch areas cracking or breaking.

Recall of Hamilton-G5 ventilators by Hamilton Medical AG due to error message.

Recall of multiple ophthalmic products by Altaire Pharmaceuticals due to potential for nonsterility.

Recall of fluorouracil injection by Fresenius Kabi USA due to potential for glass particulate.

Recall of SmartSite syringe administration set by Becton Dickinson & Company (BD) due to risk of leaks.

Recall of IntraClude intra-aortic occlusion device by Edwards Lifesciences due to risk of balloon rupture.

Recall of enFlow fluid warming system disposable cartridges by Vyaire Medical due to risk of elevated aluminum level exposure to patients.

Recall of Hudson RCI Sheridan and Sheridan Endotracheal Tubes by Teleflex Medical due to connector disconnecting from the breathing circuit.

Recall of unexpired sterile drug product lots by Infusion Options Inc. due to lack of sterility assurance.

Recall of unexpired sterile drug product lots by RXQ Compounding, LLC (“RXQ”) due to lack of sterility assurance.

Recall of unexpired sterile drug product lots by Premier Pharmacy Labs due to lack of sterility assurance.

Recall of Advance Enforcer 35 Focal-Force PTA balloon catheter 6mm x 4cm by Cook Medical due to balloons bursting below the rated burst pressure.

FDA issued a warning about the risk of transmitting multidrug resistant organisms (MRDOs) via fecal microbiota transplant (FMT).

Recall of losartan potassium to 50 mg and 100 mg tablets USP by Teva Pharmaceuticals USA due to impurity.

Recall of Candy King - Worms 3 mg 100 mL by Drip More due to elevated nicotine.

Recall of PECGEN DMX by NOVIS PR due to labeling error.

Recall of SOLOPATH Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System by Terumo Medical Corporation due to dislodgement of the fairing tip from the sheath.

Heritage Pharmaceuticals issued a voluntary recall of specific lots of amikacin sulfate and prochlorperazine edisylate injections on May 28, 2019, due to possible lack of sterility.

Recall of amikacin sulfate injection, USP 1gm/4 mL (250mg/mL) and prochlorperazine edisylate injection, USP 10mg/2mL (5mg/mL) by Heritage Pharmaceuticals due to sterility test failure.

Recall of veterinary products by Norbrook Laboratories Limited due to potential lack of sterility.

Recall of all sterile compounded drugs by Pharm D Solutions due to potential lack of sterility.

Recall of LimiTorr Volume Limiting CSF Drainage System and the MoniTorr ICP External CSF Drainage and Monitoring System by lntegra LifeSciences due to possible breakage.

Recall of EV1000 Clinical Platforms by Edwards Lifesciences due to electrical short circuit.