Argon Medical Devices Catheter Introducer Kit, PCI Kit with Feather Dilator - Pediatric, 6F, Part Number 496310, Lot Num

FDA device recall Z-2085-2011 · posted 2011-04-27 · Terminated

Recall details

Recalling firm

Argon Medical Devices, Inc

Reason for recall

Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside.

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.

Root cause

Other

Status

Terminated

Product code

FTN

Quantity affected

50 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, Sin

Date initiated

2011-03-14

Date posted

2011-04-27

Date terminated

2012-04-24

Location

Athens, TX