—#98941

Product

Argon Medical Devices, Arterial Line Kit/1 18ga x 6", Part Number 498104, Lot numbers 99767186 and 99768103 Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier.

FDA product code: FTN — Plastic Surgery And Accessories Kit
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot numbers 99767186 and 99768103

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Argon Medical Devices, Inc
Address: 1445 Flat Creek Rd, Athens, Texas 75751

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2011-03-14
Posted by FDA: 2011-04-27
Terminated: 2012-04-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #98941. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.