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U.S. Department of Health and Human Services

Class 2 Device Recall Dispensing Pins for Air Inlet Filter

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  Class 2 Device Recall Dispensing Pins for Air Inlet Filter see related information
Date Initiated by Firm January 31, 2022
Create Date March 07, 2022
Recall Status1 Open3, Classified
Recall Number Z-0727-2022
Recall Event ID 89487
510(K)Number K925401  K942988  
Product Classification Set, i.V. Fluid transfer - Product Code LHI
Product Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiration or injection of medication or enteral feeding solution from inverted multi-dose vials.
Code Information Product Code 412005 Lot Number 0061788969 Expiration date 5/31/2026 GUDID 04022495769633
Recalling Firm/
Manufacturer
B. Braun Medical, Inc.
901 Marcon Blvd
Allentown PA 18109-9512
For Additional Information Contact Jonathan Severino
833-426-1464
Manufacturer Reason
for Recall
This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inlet Filter may increase the risk of decreasing the dose of medication delivered to the patient, cause delays in treatment due to the need to replace the device or may cause contamination of the fluid path that can lead to bloodstream infection.
FDA Determined
Cause 2
Under Investigation by firm
Action On January 31, 2022, the firm distributed Urgent Medical Device Recall Notification letters to customers. If you are a distributor, please forward this recall notification to your customers. The recall is to be extended to the end user/customer level. Determine your current inventory of the affected lots within your facility, cease use and quarantine product subject to recall. Do not destroy any affected product. Record the total number of individual units (within partial cases) and the number of full-unopened cases on the Product Removal Acknowledgement form. If you have no inventory remaining, please enter zero (0) on the form. 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). A BBMI Customer Support Representative provide instructions for handling the affected product and arrange for return to BBMI. This may include credit or replacement product.
Quantity in Commerce 15,550 ea (US); 900 ea (OUS)
Distribution US Nationwide distribution in the states of AZ, CA, FL, LA, MI, MO, MS, NC, NJ, OH, PA, TN, TX, and UT. The country of 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LHI and Original Applicant = B. BRAUN OF AMERICA, INC.
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