Recall Z-2084-2011 ยท FTN Plastic Surgery And Accessories Kit
Argon Medical Devices, Inc
Argon Medical Devices, Catheter Introducer Kit, Argon PCI Kit with Feather Dilator - Pediatric, 4F, Part Number 496308, Lot Number 99767641 Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. For percutaneous introduction of catheters.
| Date | Apr 27, 2011 (initiated Mar 14, 2011) |
| Status | Terminated |
| Reason | Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside. |
| Root cause | Other |
| Action | Argon Medical Devices sent an Urgent Medical Device Recall letter dated March 14, 2011, by certified mail to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify, quarantine and return any product remaining at their facility utilizing the instruction on the 2011 Tray Recall Response Form. Customers were instructed to complete the response form included with the letter and return by fax or email as indicated as soon as possible. Customers were instructed to pass the notice on to all those |
| Quantity | 10 units |
| Distribution | Worldwide Distribution - USA including AL, AZ, CA, CO, DE, GA, HI, IL, IN, LA, MD, MN, ND, NE, NH, NJ, NY, OK, PA, SC, TX, VA, WA, and WI and the countries of Nationwide, Japan, Australia, Canada, Singapore, and the Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.