FDA Enforcement
Class II
Terminated
"3.2MM Pellet Insertion Tray with Medium Gloves" Catalog Number: B1351
Recall: Z-1180-2022
·
Reported June 8, 2022
Enforcement
- Recall Number
- Z-1180-2022
- Event ID
- 90072
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Busse Hospital Disposables, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 8, 2022
- Initiation Date
- February 22, 2022
- Classification Date
- May 28, 2022
- Termination Date
- April 17, 2024
- Address
- 75 Arkay Dr, N/A, Hauppauge, NY, 11788-3707, United States
Description
"3.2MM Pellet Insertion Tray with Medium Gloves" Catalog Number: B1351
Reason
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
Code Info
Lot Numbers: 2110082 2110174 2110254 2110221 UDI: 00849233004733
Distribution
Nationwide
Quantity
120 units