Dispensing Pin recallZ-0727-2022 · B. Braun Medical, Inc. · initiated Jan 31, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from B. Braun Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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 [email protected] 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.
Recall details
- Recall number
- Z-0727-2022
- Status
- Terminated
- Initiated by the company
- Jan 31, 2022
- Recalling firm
- B. Braun Medical, Inc.
- Quantity
- 15,550 ea (US); 900 ea (OUS)
- Product code
- LHI
- FDA submissions
- K925401, K942988
- 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.
Product description
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 (models, lots, serial numbers)
Product Code 412005 Lot Number 0061788969 Expiration date 5/31/2026 GUDID 04022495769633
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Dispensing Pin 412005B. Braun Medical Inc. · Set, i.V. Fluid transfer1 recall6 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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