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U.S. Department of Health and Human Services

Class 2 Device Recall 7F Locking Tearaway Introducers

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  Class 2 Device Recall 7F Locking Tearaway Introducers see related information
Date Initiated by Firm September 01, 2005
Date Posted January 06, 2006
Recall Status1 Terminated 3 on January 05, 2006
Recall Number Z-0346-06
Recall Event ID 33892
Product Classification Introducer, Catheter - Product Code DYB
Product 7F Locking Tearaway Introducers non-sterile. Part number 614006. The product is packaged as 50 units per pouch, 2 pouches per carton.
Code Information Lot numbers 60710907 and 60710908
Recalling Firm/
Manufacturer		 B. Braun Medical, Inc.
901 Marcon Blvd
Allentown PA 18109-9512
For Additional Information Contact Kimberly Paris
610-536-2669
Manufacturer Reason
for Recall		 Tear away sheath assembly may contain a sheath (8FR) that is not the correct French size for the dilator (7FR).
FDA Determined
Cause 2		 Other
Action The recalling firm telephoned their customers on 91/05 & 9/14/05 to inform them of the problem.
Quantity in Commerce 8000 units
Distribution The product was shipped to two consignees that repack the product into their own kits.
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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