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

Recall Z-2198-2013 — ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the foil-pouched cuvettes refrigerated 2-8C (36 - 36F); MATERIALS PROVIDED; ProTime cuvettes with Tenderlett Plus; or; Protime3 cuvettes with Tenderlett Plus LV; Product Instructions; Antiseptic, gauze (with self-test packa

U.S. FDA — Device Enforcement · United States · 2013-07-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2198-2013
Date of alert
2013-07-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Assuramed
Product category
device
Product type
Devices
Reported risk: The products may have been stored at temperatures outside their required storage conditions.
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.

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