—#191726

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.

FDA product code: LHI — Set, I.V. Fluid Transfer
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K925401, K942988
Affected lot / code info: Product Code 412005 Lot Number 0061788969 Expiration date 5/31/2026 GUDID 04022495769633

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: B. Braun Medical, Inc.
Address: 901 Marcon Blvd, Allentown, Pennsylvania 18109-9512

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2022-01-31
Terminated: 2024-04-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #191726. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.