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U.S. Department of Health and Human Services

Class 1 Device Recall Infusomat Space Volumetric Infusion Pump Administration Set

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  Class 1 Device Recall Infusomat Space Volumetric Infusion Pump Administration Set see related information
Date Initiated by Firm May 01, 2019
Date Posted September 23, 2019
Recall Status1 Terminated 3 on July 13, 2020
Recall Number Z-2489-2019
Recall Event ID 82966
510(K)Number K142036  
Product Classification Set, administration, intravascular - Product Code FPA
Product B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032
Code Information Lot Number 0061641410
Recalling Firm/
Manufacturer		 B. Braun Medical, Inc.
901 Marcon Blvd
Allentown PA 18109-9512
For Additional Information Contact Patrick Witmer
610-997-4875
Manufacturer Reason
for Recall		 Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site).
FDA Determined
Cause 2		 Other
Action Urgent Medical Device - Recall Notification letters dated 4/30/19 were sent to customers.
Quantity in Commerce 2580
Distribution Distribution to US state of TX, and Canada.
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 = FPA and Original Applicant = B. BRAUN MEDICAL, INC.
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