Cardinal Health: Medical Device Recall in 2021 - (Recall #: Z-0369-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 2, 2021

Date Posted: December 22, 2021

Recall Number: Z-0369-2022

Event ID: 89015

Reason for Recall:

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

Status: Ongoing

Product Quantity: 169,262 units

Code Information:

Lot Numbers: 20MFQ001 20MFQ002 20MFQ003 21AFQ001 21BFQ001 21BFQ002 21CFQ001 21CFQ002 21CFQ003 21DFQ001 21DFQ002 21EFQ001 21EFQ002 21FFQ001 21FFQ002 21GFQ001 21GFQ002 21GFQ003 21HFQ001 21JFQ001 UDI: 50885380172500 (cs) 10885380172502 (ea)

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.

Voluntary or Mandated:

Voluntary: Firm initiated