Device product
Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807. The percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.
Z-2576-2018
Product summary
- Event
- Event 80378
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60 units
- Official record key
device-enforcement:Z-2576-2018
Official wording
Reason: Product contains dry natural rubber latex. Label states Latex Free.
Code information: Lot/Batch Number: 13F18A0037 Expiration Date/Expected Life: Apr 2019
Distribution pattern: Puerto Rico
Derived failure modes
-
Unknown
Product contains dry natural rubber latex. Label states Latex Free.