Z-0195-2016Class II

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

Name: Z-0195-2016 Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a...
Creator: Alcon Research, Ltd.
Published: 2015-09-21
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2015-09-21 / Terminated / root cause: labeling and UDI

FDA source

Alcon Research, Ltd. began a recall of Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure on 2015-09-21. FDA classified it as Class II and gives the reason as "The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than the specified non-latex gloves". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0195-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-21
Posted: 2015-10-30
Terminated: 2016-03-24
Recalling firm: Alcon Laboratories
Product: Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.
Product code: LRO General Surgery Tray
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.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
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.
Quantity in commerce: 5 units
Distribution: Distributed in VT.
Product codes and lots: 1792733H, 1783925H, 1785227H, 1786729H

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0195-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0195-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-11	2015-10-30

Product code LRO

K880961Class IIAlcon Surgical Procedure PacksAlcon Laboratories / cleared 1988-04-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)