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U.S. Department of Health and Human Services

Class 2 Device Recall Custom Sterile

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 Class 2 Device Recall Custom Sterilesee related information
Date Initiated by FirmJune 27, 2003
Date PostedJuly 24, 2003
Recall Status1 Terminated 3 on September 22, 2005
Recall NumberZ-1023-03
Recall Event ID 26609
Product Classification General Surgery Tray - Product Code LRO
ProductCatalog SBA61MJSFH, Sterile Laparotomy Pack, Mfg date 5/21/03, order 101438;
Code Information Catalog SBA61MJSFH, Sterile Laparotomy Pack, Mfg date 5/21/03, order 101438; 
FEI Number 3001236905
Recalling Firm/
Manufacturer		 Cardinal Health
1500 Waukegan Rd, Bldg K
Mcgaw Park IL 60085-6787
For Additional Information ContactQuality Systems Professional Services
800-292-9332
Manufacturer Reason
for Recall		The kits labeled as sterile were stolen in transit to the sterilizer and have not been sterilized.
FDA Determined
Cause 2		Other
ActionThe customers who ordered the custom packs were notified of the theft of the unsterilized packs via letter dated 6/27/03, sent via Airborne Express. The accounts were requested to inspect their inventory for the affected catalog numbers and order/lot numbers, and segregate any of the product found for return and replacement.
DistributionNew Jersey, Tennessee, Missouri and Minnesota
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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