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U.S. Department of Health and Human Services

Class 2 Device Recall SafeSheath

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  Class 2 Device Recall SafeSheath see related information
Date Initiated by Firm June 11, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on June 27, 2005
Recall Number Z-1086-04
Recall Event ID 29395
Product Classification Introducer, Catheter - Product Code DYB
Product SafeSheath CSG (Coronary Sinus Guide) KR-90.09 and CSG (Coronary Sinus Guide) KR/BCor-90.09. These sheaths are packaged in 5 individual boxed kits per case carton.
Code Information All lot numbers are affected.
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 Ext. 214
Manufacturer Reason
for Recall
Degradation of sheath due to excessive exposure to (ultra violet) fluorescent light.
FDA Determined
Cause 2
Other
Action The recalling firm send a recall letter via fax and Federal Express 6/11/2004 to the various wholesalers and/or distributors informing them of the recall and to return all product to the recalling firm.
Quantity in Commerce 39,605 kits
Distribution The recall product was distributed to various distributors in the following states: CA and PA. There are no foreign or government accounts.
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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