Argon Medical Devices Catheter Introducer Kit, PCI Kit with Feather Dilator - Pediatric, 6F, Part Number 496310, Lot Number 99767643 Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. For percutaneous introduction of catheters.
This recall has been terminated (originally issued April 27, 2011).
- Company
- Argon Medical Devices, Inc
- Recall Initiated
- March 14, 2011
- Posted
- April 27, 2011
- Terminated
- April 24, 2012
- Recall Number
- Z-2085-2011
- Quantity
- 50 units
- Firm Location
- Athens, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside.
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
Lot / Code Info
Lot number 99767643
Root Cause
Other
Action Taken
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 who need to be aware within their organization or to any organization where the potentially affected devices have been transferred. For questions regarding this recall call (903) 677-9375.