Z-0899-2018 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 14, 2018
- Initiation Date
- October 3, 2017
- Termination Date
- October 21, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,000 units
Product Description
Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.
Reason for Recall
Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue is related to the production lot P1607442 only.
Distribution Pattern
US Distribution to Puerto Rico.
Code Information
Lot No P1607442.