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U.S. Department of Health and Human Services

Class 2 Device Recall V. Mueller Peanut Sponges

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 Class 2 Device Recall V. Mueller Peanut Spongessee related information
Date Initiated by FirmMarch 01, 2010
Date PostedAugust 27, 2010
Recall Status1 Terminated 3 on November 02, 2011
Recall NumberZ-2296-2010
Recall Event ID 56420
Product Classification Gauze/sponge, internal, x-ray detectable - Product Code GDI
ProductV. 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.
Code Information Product Code: 23275-470, Lot number 3405
Recalling Firm/
Manufacturer		 He, Inc
4052 Indian Creek Rd
Martinez GA 30907-2234
For Additional Information ContactNorris R. Harod
706-228-5165
Manufacturer Reason
for Recall		Sterile product packaging contains weak seals, which may result in compromised product sterility.
FDA Determined
Cause 2		Packaging
ActionHarod 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.
Quantity in Commerce551 cases of 100 packages per case
DistributionNationwide: including state of IL.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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