Z-1387-2018 Class II Terminated
FDA device recall Z-1387-2018 was initiated by Preservation Solutions, Inc. on February 26, 2018 and is designated Class II. Reason for recall: Bags of solution may have a small leak at the base of the injection port where the port is welded into the body of the bag.. The recall status is terminated (terminated September 9, 2022). Affected quantity: 31,104 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 25, 2018
- Initiation Date
- February 26, 2018
- Termination Date
- September 9, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31,104 units
Product Description
Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US; and, Belzer UW Cold Storage Solution, Catalog No. BUW_002. Intended for the hypothermic flushing and storage of specific organs in preparation for storage, transportation, and transplantation into a recipient.
Reason for Recall
Bags of solution may have a small leak at the base of the injection port where the port is welded into the body of the bag..
Distribution Pattern
Worldwide Distribution -- USA and Europe.
Code Information
UDI 00810805000163, and UDI 00810805000071.