Z-0899-2018 Class III Terminated
FDA device recall Z-0899-2018 was initiated by Degania Silicone, Ltd. on October 3, 2017 and is designated Class III. 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. The recall status is terminated (terminated October 21, 2020). Affected quantity: 4,000 units.
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.