Health product recall

HALYARD* PUREZERO* Ultraviolet* Nitrile Exam Gloves

Last updated

Summary

Product
HALYARD* PUREZERO* Ultraviolet* Nitrile Exam Gloves
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
HALYARD* PUREZERO* Ultraviolet* Nitrile Exam Gloves SJ504832X LFS511MD

Issue

The issue surrounding this field action is related to not meeting the minimum breakthrough time of 30 minutes for n-Heptane required for European Type B performance per ISO 374-1:2016+A1:2018 and EN 16523-1:2015+A1:2018. No other product codes or lots of gloves are impacted in this field action.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
O & M Halyard, Inc.
1220 Old Alpharetta Rd, Alpharetta, Georgia, United States, 30005
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82197

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