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

Recall Z-0897-2014 — 25ga Mid-Field Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.22.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

U.S. FDA — Device Enforcement · United States · 2013-12-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0897-2014
Date of alert
2013-12-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Synergetics Inc
Product category
device
Product type
Devices
Reported risk: Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
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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