Exact FDA event identifier

Event 79378

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: February 26, 2018
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Preservation Solutions, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1387-2018

Recall number: Z-1387-2018
Initiated: February 26, 2018
Classification: Class II
Status: Terminated
Recalling firm: Preservation Solutions, Inc.
Quantity: 31,104 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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..

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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..

Code information

UDI 00810805000163, and UDI 00810805000071.

Distribution pattern

Worldwide Distribution -- USA and Europe.