Z-0727-2022Class II

Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for...

Name: Z-0727-2022 Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for...
Creator: B. Braun Medical, Inc.
Published: 2022-01-31
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2022-01-31 / Terminated

FDA source

B. Braun Medical, Inc. began a recall of 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... on 2022-01-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0727-2022
Classification: Class II
Status: Terminated
Initiated: 2022-01-31
Posted: 2022-03-07
Terminated: 2024-04-29
Recalling firm: B Braun Medical Inc
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.
Product code: LHI Set, I.V. Fluid Transfer
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 root cause: 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 [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.
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.
Product codes and lots: Product Code 412005 Lot Number 0061788969 Expiration date 5/31/2026 GUDID 04022495769633

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0727-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0727-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-16	2022-03-07

Product code LHI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)