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U.S. Department of Health and Human Services

Class 2 Device Recall Filtered TripleLeg Extension Set

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 Class 2 Device Recall Filtered TripleLeg Extension Setsee related information
Date Initiated by FirmMarch 15, 2021
Create DateApril 29, 2021
Recall Status1 Terminated 3 on June 07, 2022
Recall NumberZ-1509-2021
Recall Event ID 87585
510(K)NumberK153293 K942988 
Product Classification Set, administration, intravascular - Product Code FPA
ProductFiltered Triple-Leg Extension Set - Intravascular administration set. Product Catalog number: 477034 - Product Usage: The extension set is a sterile, single-use intravascular direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications.
Code Information Lot #: 00SL713784, 0061741483, 0061755034, 0061755296
Recalling Firm/
Manufacturer		 B. Braun Medical, Inc.
901 Marcon Blvd
Allentown PA 18109-9512
For Additional Information ContactTiffany Williams
610-596-2363
Manufacturer Reason
for Recall		BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 03/12/2021, B. Braun issued an Urgent Medical Device Recall notice via letter notifying customers of the potential for the extension set to become occluded or unable to prime.
Quantity in Commerce1,900 units
DistributionUS Nationwide distribution in the states of NC, CA.
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
510(K)s with Product Code = FPA
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