Z-0366-2017Class II

Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove Item Number Description...

Name: Z-0366-2017 Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove Item Number Description...
Creator: Covidien LLC
Published: 2016-09-29
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2016-09-29 / Terminated / root cause: manufacturing process

FDA source

Covidien LLC began a recall of Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove Item Number Description 380789003 SURE SET SINGLE BASIN PACK 400383006... on 2016-09-29. FDA classified it as Class II and gives the reason as "Added Instructions for Use: After application, inspect the Light Glove for barrier integrity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0366-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-29
Posted: 2016-11-08
Terminated: 2019-04-05
Recalling firm: Medtronic, Inc.
Product: Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove Item Number Description 380789003 SURE SET SINGLE BASIN PACK 400383006 MAJOR BASIN PACK 400383007 MAJOR BASIN PACK 618275004 BASIN PACK Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
Product code: LRO General Surgery Tray
Reason for recall: Added Instructions for Use: After application, inspect the Light Glove for barrier integrity
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medtronic issued a Correction Notice on September 29, 2016. Customers were notified via Federal Express and the letter informed customers of the addition of the following statement to the Instructions for Use (IFU): After application, inspect the Light Glove for barrier integrity. Questions or concerns, contact your Medtronic representative or Customer Service at (800) 962-9888
Quantity in commerce: 4950 units
Distribution: Worldwide Distribution - US Nationwide Foreign: Canada: Andorra Austria Belgium Czech Republic Denmark Finland France Germany Greece Ireland Israel Italy Latvia Luxembourg Monaco Netherlands Norway Poland Portugal Russian Federation Saudi Arabia Slovenia South Africa Spain Sweden Switzerland United Arab Emirates United Kingdom
Product codes and lots: All lot codes in the following: Item Number Description 380789003 SURE SET SINGLE BASIN PACK 400383006 MAJOR BASIN PACK 400383007 MAJOR BASIN PACK 618275004 BASIN PACK

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0366-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0364-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-16	2016-11-08
Z-0365-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-16	2016-11-08
Z-0366-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-16	2016-11-08

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)