Recall Z-0727-2022 ยท LHI Set, I.V. Fluid Transfer
B. Braun Medical, Inc.
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.
| Date | Jan 31, 2022 |
| Status | Terminated |
| Reason | 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 | 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 re |
| Quantity | 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. |
| FDA record | Open on fda.gov |