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Terminated

V. Mueller Peanut Sponges, Catalog number 23275-470, Sterile, For Single Use Only, Size: 3/8, X-Ray Detectable In Holders, Distributed by Cardinal Health, McGaw Park, IL 60085 USA. There are various uses including as gauze/sponge internal, x-ray detectable and as dissectors.

FDA Recall Z-2296-2010 · Posted 2010-08-27

Recalling FirmHe, Inc
Recall StatusTerminated
Product CodeGDI
Date Initiated2010-03-01
Date Terminated2011-11-02
Product Quantity551 cases of 100 packages per case

Reason for Recall

Sterile product packaging contains weak seals, which may result in compromised product sterility.

Firm Action

Harod Enterprises, Inc. (HE) issued a "Notice of Recall" letter to Cardinal Health/V. Mueller dated March 1, 2010 identifying the issue and affected product. Cardinal Health/V. Mueller will issue a subrecall letter to all their customers (end users) instructing them to discontinue use of the affected lots and return for replacement. and will track all responses and removal of the product from their private label customers. HE will repackage and/or replace all returned product. Consignees can contact Harod Enterprises, Inc. at 1-706-228-5165.

Root Cause

Packaging

Distribution Pattern

Nationwide: including state of IL.

Official Source

View FDA Recall →

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

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