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

Recall Z-1373-2022 — Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE INSTITUTE 18527-03 14JM57 DOSS CATARACT ALLIANCE EYE SURG PARTNERS 11802-07 14KFAF GANS BASIC PACK NOVAMED EYE SURG CTR 11802-07 14LTRW GANS B

U.S. FDA — Device Enforcement · United States · 2022-06-09 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1373-2022
Date of alert: 2022-06-09
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Alcon Research, LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10380651677385

Reported risk: Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves.

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.

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.

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