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

Recall Z-1286-2015 — CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.

U.S. FDA — Device Enforcement · United States · 2015-02-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1286-2015
Date of alert
2015-02-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Smiths Medical ASD, Inc.
Product category
device
Product type
Devices
Reported risk: Smiths Medical has become aware of an issue with specific lots of 50mL CADD" Medication Cassette Reservoirs (Cassette). Some Cassettes may leak at the sealing area of the pump tube and medication bag. Smiths Medical has received no reports of serious injury or death related to this issue.
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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