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Terminated

Biopsy Forceps, Cold Model #'s: BAR000386 BAR000388 MIC1012 MIC1331 MIC1333 MIC1337 MIC1536 MIC1589 MIC1597 MIC1598 and MIC1599 The Reprocessed Cold Biopsy Forceps are intended to be used during endoscopic procedures of the gastrointestinal tract to collect tissue samples for histologic examination.

FDA Recall Z-0575-2009 · Posted 2009-01-13

Recalling FirmSterilmed Inc
Recall StatusTerminated
Product CodeNON
Date Initiated2008-08-08
Date Terminated2011-04-26
Product Quantity345

Reason for Recall

SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable

Firm Action

Consignees were notified of the recall via verbal communication in person by on-site technician and or their local sales representative on 8/8/08. Others were contacted via fax or e-mail followed by on-site visits 8/11/08. SteriMed also provided consignees (Materials Manager/Risk Manager) with a "Urgent Product Removal" recall letter (August 14, 2008) in person informing them of the potential of receiving affected product. Included in the Product Removal Notification was a Customer Reply Form to inventory quantity of product received and quantity returned. Contact SterilMed, Inc. at 1-888-541-0078 for assistance.

Root Cause

Packaging process control

Distribution Pattern

AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, and WV OUS: CANADA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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