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U.S. Department of Health and Human Services

Class 2 Device Recall Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter

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  Class 2 Device Recall Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter see related information
Date Initiated by Firm May 09, 2018
Create Date June 25, 2018
Recall Status1 Terminated 3 on December 12, 2019
Recall Number Z-2285-2018
Recall Event ID 80142
510(K)Number K142036  
Product Classification Set, administration, intravascular - Product Code FPA
Product Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420

The Infusomat Space Pump IV Set, 2 Caresites, ASV with 0.2 Micron Air Eliminating Filter and Anti-Syphon Valve (ASV) is a latex-free product intended to be used with the Infusomat Space Pump, to deliver intravenous solutions. The 0.2 Micron filter is a clear acrylic in-line filter designed to eliminate air within the IV infusion set. While it is not listed in the labeling, it is known that the filter is used for removal of particulate matter for some medications and at risk patient populations.
Code Information Lot Number: 0061583973
Recalling Firm/
Manufacturer
B. Braun Medical, Inc.
901 Marcon Blvd
Allentown PA 18109-9512
For Additional Information Contact Connie Walker
610-596-0500
Manufacturer Reason
for Recall
There is a potential for a different set to be mixed within the lot, where the incorrect set does not contain an air eliminating filter.
FDA Determined
Cause 2
Process control
Action B. Braun Medical Inc. sent an Urgent Voluntary Medical Device Recall Notification letter dated May 9, 2018. The letter included the following instructions for customers: 1. Review the Medical Device Recall Notification in its entirety and ensure that all users in your organization of the above mentioned product, and other concerned persons, are informed about this voluntary product recall and the affected product. Further use of this product should be discontinued immediately and affected product quarantined. 2. If you are a distributor, please immediately forward this recall notification to your customers. 3. Determine your current inventory of the affected lots within your facility. Do not destroy any affected product. 4. Utilizing the attached "Product Removal Acknowledgement" form, record the total number of individual units (within partial cases) and the number of full-unopened cases. If you have no inventory remaining, please enter zero (0) on the form. 5. Return the completed "Product Removal Acknowledgement" form to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to PA_QualityAssurance.BBMUS_Service@bbraunusa.com within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). It is important this form is returned, so BBMI can meet its United States Food and Drug Administration regulatory requirement. 6. If you have any full cases, partial cases or unused individual pieces of these affected products as identified in the " Product Removal Acknowledgement" form that was submitted to BBMI Quality Assurance Department, a BBMI Customer Support Representative will contact you to provide instructions for handling the affected product and arrange for return to BBMI. This may include credit or replacement product. For further questions, please call (610) 596-0500.
Quantity in Commerce 1,872
Distribution US Distribution to the states of : CA, IL, and TX., and Internationally to 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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