Recall Z-0369-2022— Cardinal Health

Name: FDA recall Z-0369-2022
Creator: U.S. Food and Drug Administration
Published: 2021-11-02

Class II · Ongoing

Class II FDA medical device recall by Cardinal Health, initiated 2021-11-02. It names one FDA 510(k) clearance: K023167. Product: SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011. Reason: Potential for open packaging seals compromising the sterility of the surgical gowns.

Recalling firm: Cardinal Health
Classification: Class II
Status: Ongoing
Initiated: 2021-11-02
Firm location: Waukegan, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K023167 — BREATHABLE SURGICAL GOWNAllegiance Healthcare Corp.·cleared 2002-10-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011

Reason for recall

Potential for open packaging seals compromising the sterility of the surgical gowns

Data sourced from openFDA. This site is unofficial and independent of the FDA.