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

Recall Z-2679-2016 — DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O,

U.S. FDA — Device Enforcement · United States · 2016-08-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2679-2016
Date of alert
2016-08-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
DeRoyal Industries Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
40004006
Reported risk: The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap. The BARD(TM) component is being recalled for a possible slit defect on the package that may affect the component's sterility.
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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