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U.S. Department of Health and Human Services

Class 2 Device Recall B. Braun HyperFormer Pump Dispensing Set

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 Class 2 Recall
B. Braun HyperFormer Pump Dispensing Set
see related information
Date Posted May 05, 2007
Recall Status1 Terminated on August 07, 2007
Recall Number Z-0783-2007
Recall Event ID 37855
Premarket Notification
510(K) Number
K905201 
Product Classification Set, I.V. Fluid Transfer - Product Code LHI
Product B.Braun HyperFormer Pump Dispensing Set, Catalog Number V9900-02. The product is shipped in cases containing 10 sets.
Code Information Lot number 0060911602
Recalling Firm/
Manufacturer
B. Braun Medical, Inc.
901 Marcon Boulevard
Allentown, Pennsylvania 18109-9512
For Additional Information Contact Kimberly Paris
610-266-0500
Manufacturer Reason
for Recall
The integrity of the sterile product barrier may be compromised
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action An Urgent Product Removal Notice was issued to the distributors on 4/11/07. The notice informs the distributors of the problem, the need to conduct a sub recall and to return the product.
Quantity in Commerce 180 units
Distribution Nationwide distribution --- including states of GA, MA, OH, and TX
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LHI and Original Applicant = MCGAW, INC.
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