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

Recall Z-1767-2017 — CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO.

U.S. FDA — Device Enforcement · United States · 2017-03-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1767-2017
Date of alert
2017-03-17
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 that the drawing on the Instructions for Use (IFU) on certain yellow striped CADD¿ Administration Sets (part number 21-7339-24), incorrectly represent the actual filter size of the product. Although the text description on the IFU correctly identifies the product to include a 0.2 micron filter, the illustration on the IFU identifies the filter size as 2.0 microns.
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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