Z-1157-2022 Class II Terminated

Recalled by Busse Hospital Disposables, Inc. — Hauppauge, NY

Recall Details

Product Type
Devices
Report Date
June 8, 2022
Initiation Date
February 22, 2022
Termination Date
April 17, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4218 units

Product Description

I.V. Start Kit Catalog 8172

Reason for Recall

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Distribution Pattern

Nationwide

Code Information

Lot Numbers: 2020561 2020560 2020650 2120089 2120018 2120344 2120442 2120645 2120768 2120911 UDI: 00849233015883