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U.S. Department of Health and Human Services

Class 2 Device Recall SafeSheath KR under the Pressure Products label

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  Class 2 Device Recall SafeSheath KR under the Pressure Products label see related information
Date Initiated by Firm October 14, 2004
Date Posted October 28, 2004
Recall Status1 Terminated 3 on January 24, 2006
Recall Number Z-0058-05
Recall Event ID 30242
Product Classification Introducer, Catheter - Product Code DYB
Product SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number HLS/KR-1011. The product is shipped in cartons containing 5 units
Code Information Lot number F6824 exp. 8/06
Recalling Firm/
Manufacturer		 Thomas Medical Products Inc
65 Great Valley Pkwy
Malvern PA 19355-1302
For Additional Information Contact Peter J. Rapp
610-296-3000
Manufacturer Reason
for Recall		 Sheaths may fracture if exposed to excess fluorescent light
FDA Determined
Cause 2		 Other
Action The recalling firm issued a letter to the distributor on 10/15/04 via fax and Federal Express. The letter informed them of the product and the need to return the product. The account was instructed to conduct a sub-recall.
Quantity in Commerce 795 kits
Distribution The product was shipped to the label owner/distributor in CA.
Total Product Life Cycle TPLC 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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