Recall Z-0789-2020
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 Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Codes / lots: Batch 6917183; UDI (01)15414734014219(17)220228(10)6917183 Batch 6950628; UDI (01)15414734014219(17)220331(10)6950628 Batch 7099144; UDI (01)15414734014219(17)220630(10)7099144
Reason for recall
Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices.
FDA-determined cause: Packaging
Action taken
Beginning on December 9, 2019, US consignees will be notified in person by an Abbott field representative. OUS consignees will be notified by mail. The firm is seeking return of the devices.
Details
- Recall number
- Z-0789-2020
- Initiated
- December 9, 2019
- Terminated
- December 11, 2020
- Product code
- DYB – Introducer, Catheter
- Quantity
- 380 devices
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of MA, VA, NH, FL, CT, UT, OH, WI, NY, IA, MI, MS, PA, and countries of Canada, Czech Republic
- Recalling firm
- Abbott Medical, Plymouth, MN