Z-2576-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 8, 2018
- Initiation Date
- May 23, 2018
- Termination Date
- May 20, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60 units
Product Description
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.
Reason for Recall
Product contains dry natural rubber latex. Label states Latex Free.
Distribution Pattern
Puerto Rico
Code Information
Lot/Batch Number: 13F18A0037 Expiration Date/Expected Life: Apr 2019