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Terminated

Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.

FDA Recall Z-0195-2016 · Posted 2015-10-30

Recalling FirmAlcon Research, Ltd.
Recall StatusTerminated
Product CodeLRO
Date Initiated2015-09-21
Date Terminated2016-03-24
Product Quantity5 units

Reason for Recall

The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than the specified non-latex gloves.

Firm Action

The recalling firm notified the consignee on 9/21/15 via phone call, and with a follow up visit to the consignee site. The recalled units were recovered.

Root Cause

Mixed-up of materials/components

Distribution Pattern

Distributed in VT.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K880961ALCON SURGICAL PROCEDURE PACKSAlcon Laboratories · 1988-04-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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