Recall Z-0783-2020
Abbott Medical · initiated December 9, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Codes / lots: UDI: (01)15414734203903(17)220731(10)7133555, Batch: 7133555
Reason for recall
Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices.
FDA-determined cause: Packaging
Action taken
Beginning on 12/09/2019, consignees were notified in person by an Abbott field representative. The firm is seeking return of the affected units. For questions about this issue or for replenishment contact your local Abbott Representative or Abbott Support at 1-855-478-5833 (option 1).
Details
- Recall number
- Z-0783-2020
- Initiated
- December 9, 2019
- Terminated
- December 14, 2020
- Product code
- DYB – Introducer, Catheter
- Quantity
- 814 devices
- Distribution
- Worldwide Distributed - US Nationwide in sates of: FL, PA, NY, TX, MI CA, IL, NE, AL, NV, including PR and the countries of: Malaysia, Korea, Paraguay
- Recalling firm
- Abbott Medical, Plymouth, MN