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Surgical Instruments

🏥 Medical Devices • 6,839 recalls

CHS Custom Convenience Kit-SURGICAL GOWN, LARGE SET IN SLEEVES Product Number:1231-050L

Custom Healthcare Systems

Class I - Dangerous

Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility

Aug 13, 2018 Surgical Instruments View Details →

Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]

Ecolab

Class I - Dangerous

The pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel within the seal. Should there be a channel in the pouch seal it may result in a breach in the sterility of the product.

Sep 14, 2018 Surgical Instruments Nationwide View Details →

CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 1231-080XL GOWN, SURGICAL XXL 1231-150XL GOWN, SURGICAL XXL

Custom Healthcare Systems

Class I - Dangerous

Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility

Aug 13, 2018 Surgical Instruments View Details →

McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only.

Cypress Medical Products

Class I - Dangerous

Small hole at the end of the syringe is impeding suction of liquid.

Sep 4, 2018 Surgical Instruments Nationwide View Details →

Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309; (b) medium curl (22.4 mm curve type/71 cm length), Product Code STJ408310; (c) large curl (50 mm curve type/71 cm length), Product Code STJ408324

Sterilmed

Class I - Dangerous

Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.

Sep 17, 2018 Surgical Instruments Nationwide View Details →

CE17TKFSDTD EPID TRAY W/17GA FIXED WING, Material Number 332095 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical

Class I - Dangerous

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.