Z-0727-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 16, 2022
- Initiation Date
- January 31, 2022
- Termination Date
- April 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,550 ea (US); 900 ea (OUS)
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.
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.
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.
Code Information
Product Code 412005 Lot Number 0061788969 Expiration date 5/31/2026 GUDID 04022495769633