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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 Device Recall B. Braun HyperFormer Pump Dispensing Set see related information
Date Initiated by Firm April 11, 2007
Date Posted May 05, 2007
Recall Status1 Terminated 3 on August 07, 2007
Recall Number Z-0783-2007
Recall Event ID 37855
510(K)Number K905201  
Product Classification HyperFormer Pump Dispensing Set, - 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/
B. Braun Medical, Inc.
901 Marcon Boulevard
Allentown PA 18109-9512
For Additional Information Contact Kimberly Paris
Manufacturer Reason
for Recall
The integrity of the sterile product barrier may be compromised
FDA Determined
Cause 2
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 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.
510(K) Database 510(K)s with Product Code = LHI and Original Applicant = MCGAW, INC.