Cardinal Health Custom Surgery Packs (2020-01-31)

Starting date:

January 31, 2020

Posting date:

February 20, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-72385

Last updated: 2020-02-20

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  Reason
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  Affected products

Affected Products

More than 10 products, contact manufacturer.

Reason

Cardinal Health is conducting this recall because the Presource Packs contain the recalled Cardinal Health Non-Reinforced Surgical Gowns, Cardinal Health Fabric-Reinforced Surgical Gowns and/or RoyalSilk Non-Reinforced Surgical Gowns. Cardinal Health initiated the surgical gown voluntary recall because some of the affected gowns were manufactured at locations that did not maintain proper environmental conditions as required by law, were not qualified by Cardinal Health and were comingled with properly manufactured gowns.

Affected products