FDA recall Z-1189-2022

Product

SS 4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1365R1

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

Nationwide

Key facts

Status

Terminated

Initiation date

2022-02-22

Report date

2022-06-08

Termination date

2024-04-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hauppauge, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1189-2022