Preservation Solutions, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1387-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 26, 2018

Date Posted: April 25, 2018

Recall Number: Z-1387-2018

Event ID: 79378

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..

Status: Terminated

Product Quantity: 31,104 units

Code Information:

UDI 00810805000163, and UDI 00810805000071.

Distribution Pattern:

Worldwide Distribution -- USA and Europe.

Voluntary or Mandated:

Voluntary: Firm initiated