Device product
LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10
Z-0473-2019
Product summary
- Event
- Event 81391
- Status
- Terminated
- Classification
- Class II
- Quantity
- 46 units
- Official record key
device-enforcement:Z-0473-2019
Official wording
Reason: Pouches from this lot are not sealed compromising the sterility
Code information: LOT# PFP1055 Expiration Date: 2020-03-28
Distribution pattern: FL Foreign: Austalia, Korea
Derived failure modes
-
Unknown
Pouches from this lot are not sealed compromising the sterility