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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 Introducerssee related information
Date Initiated by FirmSeptember 01, 2005
Date PostedJanuary 06, 2006
Recall Status1 Terminated 3 on January 05, 2006
Recall NumberZ-0346-06
Recall Event ID 33892
Product Classification Introducer, Catheter - Product Code DYB
Product7F 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 ContactKimberly 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
ActionThe recalling firm telephoned their customers on 91/05 & 9/14/05 to inform them of the problem.
Quantity in Commerce8000 units
DistributionThe product was shipped to two consignees that repack the product into their own kits.
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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