Health product recall

Adaptic Non-Adhering Dressing, 7.6CM X 7.6CM (2019-08-02)

Starting date:
August 2, 2019
Posting date:
August 23, 2019
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-70775

Last updated: 2019-08-23

Affected Products

Adaptic Non-Adhering Dressing, 7.6CM X 7.6CM

Reason

KCI USA, INC. (KCI) and Systagenix Wound Management (Systagenix) have become aware of potential sterile barrier breaches in some of the pouches of the Adaptic Non-Adhering Dressing (product code/sku number 2012), lot number 1903v001. No other products or lot numbers are impacted by this voluntary medical device recall. Neither KCI nor Systagenix have received any reports of patient injury or complications as a result of a sterile barrier breach for any Adaptic Non-Adhering Dressing.

Affected products

Adaptic Non-Adhering Dressing, 7.6CM X 7.6CM

Lot or serial number

1903V001

Model or catalog number

2012

Companies
Manufacturer

KCI USA, Inc.

12930 IH 10 WEST

San Antonio

78249

Texas

UNITED STATES