Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall Infusomat Space Volumetric Infusion Pump Administration Set

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 1 Device Recall Infusomat Space Volumetric Infusion Pump Administration Setsee related information
Date Initiated by FirmMay 01, 2019
Date PostedSeptember 23, 2019
Recall Status1 Terminated 3 on July 13, 2020
Recall NumberZ-2489-2019
Recall Event ID 82966
510(K)NumberK142036 
Product Classification Set, administration, intravascular - Product Code FPA
ProductB.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 ContactPatrick 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
ActionUrgent Medical Device - Recall Notification letters dated 4/30/19 were sent to customers.
Quantity in Commerce2580
DistributionDistribution to US state of TX, and Canada.
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.
510(K) Database510(K)s with Product Code = FPA
-
-