Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1387-2018 — 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

U.S. FDA — Device Enforcement · United States · 2018-02-26 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1387-2018
Date of alert: 2018-02-26
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Preservation Solutions, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00810805000163

Reported risk: 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..

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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