🏥 Medical Devices • 6,839 recalls
Stryker Neurovascular
Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack.
Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack.
Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve.
Manufactured with the incorrect anchor outer body
The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.
Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm.
A small number of batches may crack or break if exposed to certain chemicals, like certain cleaning agents.
Custom surgical kits contain Aplicare Povidone Iodine Prep Pads which were subsequently recalled by Medline Industries for incorrect expiration date.
Becton Dickinson & Company
Hub damage resulting in breakage and/or leakage during use.
The firm received reports of two breakages of the pin tips which occurred during two identical surgery procedures. The breakage occurred at the very distal end of the conical part of the skull pin tip.
Biosense Webster
Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.
Biosense Webster
Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.
Zimmer Biomet
Issue with optional neuro-endoscopy module detected under specific conditions during internal testing.
There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.
Becton Dickinson & Company
Product mislabel. Lot 6291768 of the BD Insulin Syringes with the BD Ultra-Fine needle ¿mL 12.7mm 30G, Cat (Ref) 328466, was found to have some polybags in the lot incorrectly labeled as BD Ultra-Fine needle ¿mL 8mm 31G, Cat (Ref) 328468. The shelf carton and case carton are correctly labeled as BD Ultra-Fine needle ¿mL 12.7mm 30G.
Zimmer Biomet
Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended).
Resource Optimization & Innovation
Resource Optimization & Innovation, LLC (ROi) received a recall notice from BD for an incorrect label on 3ml ChloraPrep With Tint, Product Code (REF) 260415NS, NDC 054365-400-11, Lot 7096622. The label mix is at the unit level where a "ChloraPrep One-Step" unit label was incorrectly used on a certain percentage of the impacted lot instead of the correct "ChloraPrep With Tint" label. The recall notification was issued by BD on September 15, 2017 and was received by ROi on September 18, 2017. Because the 3ml ChloraPrep With Tint product is contained within select ROi Regard Custom Surgical Packs, ROi is conducting a recall of the affected ROi Regard Custom Surgical Packs.
Medline Industries
Possible open seal on top portion of the package. Could cause breach of sterility.
ICU Medical has identified certain stopcocks that are incorporated in IV sets may contain a metallic burr.
Communication errors between ROSANNA BRAIN software, MARIO software and the St¿ubli CS8C controller.