Northeast Scientific NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter Recall 173 Un
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
325 recalls tagged with “electronic”.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Wound dressing may have foreign matter on the product.
Baxter Healthcare recalls 49,200 CONTINU-FLO IV Solution Sets distributed nationwide in the United States. IV sets may leak. Healthcare facilities and patients should stop using the device immediately and follow Baxter's recall instructions.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.
Jessie Lord Bakery is recalling 136,252 cases of Lemon Meringue Pie sold at retailers in 14 states due to undeclared Yellow #5. The dye was not disclosed on packaging. Consumers should not eat the product and should seek a refund or replacement.
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.