FDA Enforcement
Class II
Terminated
I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822
Recall: Z-1147-2022
·
Reported June 8, 2022
Enforcement
- Recall Number
- Z-1147-2022
- 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
I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822
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: 2020514 2020525 2020734 2120255 2120304 2120325 2120439 UDI: 00849233010017
Distribution
Nationwide
Quantity
2475