Cook Incorporated recalls
12 recalls on record · 1 rated Critical · FDA
Every recall we have on record for Cook Incorporated, compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 ,…
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number…
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number…
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF…
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number…
Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect.
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers…
There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit components and accessories. This resulted in an unsecure connection between the device connector and circuit components, cap, or accessories.
Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN: …
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: …
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 …
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part…
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 …
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Nester Embolization Microcoil RPN GPN …
The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.