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

Custom Pak 9319-27 — recall Z-0195-2016

U.S. FDA — Device Enforcement · United States · 2015-09-21 · Class II

As described by U.S. FDA — Device Enforcement: Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0195-2016
Date of alert
2015-09-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Alcon Research, Ltd.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Distributed in VT.
Reported risk: The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than the specified non-latex gloves.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.