Health product recall

Cardinal Health Level 3 Isolation Gowns

Last updated

Summary

Product
Cardinal Health Level 3 Isolation Gowns
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 catalog number
Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back All lots. AT6688-2XL AT6688-XL AT6588-XL AT6588-BD
Convertor Isolation Gown, AAMI Level 3 Protection All lots. AT6200 AT6100

Issue

The listed product codes and all lots of Cardinal Health Level 3 Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (the Association for the Advancement of Medical Instrumentation) level 3 protection requirements. The raw material identified has demonstrated possible degradation due to exposure to lighting, temperature, and relative humidity beyond the manufacturer recommended limits. This product recall is specific to the codes listed. Other codes are not impacted.

Recall Start Date: November 5, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies

Cardinal Health 200, Llc Also Trading As Cardinal Health

3651 Birchwood Drive, Waukegan, Illinois, United States, 60085

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76546

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