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Terminated

Argon Medical Devices, Arterial Line Kit/1, 20ga x 3", Part Number 498106, Lot numbers 99767187 and 99767388 Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier.

FDA Recall Z-2091-2011 · Posted 2011-04-27

Recall StatusTerminated
Product CodeFTN
Date Initiated2011-03-14
Date Terminated2012-04-24
Product Quantity1,820 units

Reason for Recall

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

Firm 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 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

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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