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U.S. Department of Health and Human Services

Class 2 Device Recall B Braun 9F (O/S) Locking Tearaway Introducers

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 Class 2 Device Recall B Braun 9F (O/S) Locking Tearaway Introducerssee related information
Date Initiated by FirmMay 08, 2006
Date PostedJune 24, 2006
Recall Status1 Terminated 3 on August 22, 2006
Recall NumberZ-1163-06
Recall Event ID 35554
Product Classification Tearway Introducers - Product Code DYB
ProductB Braun 9F (O/S) Locking Tearway Introducers non-sterile. Catalog number 614008. The product is packaged as 50 bulk nonsterile units per pouch, 2 pouches per shipping carton.
Code Information Lot number 60745623
Recalling Firm/
Manufacturer		 B. Braun Medical, Inc.
901 Marcon Blvd
Allentown PA 18109-9512
For Additional Information ContactKimberly Paris
610-596-2669
Manufacturer Reason
for Recall		Mislabeled-9F labeled units actually contain 10F devices
FDA Determined
Cause 2		Other
ActionThe recalling firm telephoned their consignees on 5/10/06 to inform them of the problem and the need to recall their kits
Quantity in Commerce9300 units
DistributionThe product was shipped to four consignees in FL, NY, CT, and Germany 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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