Recalls / —

—#192652

Product

Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves

FDA product code

KGO — Surgeon'S Gloves

Device class

Class 1

Medical specialty

General, Plastic Surgery

510(k) numbers

K110272

Affected lot / code info

Catalog Numbers: 1) 2D72PL65X, Lot Number TS21050195, EXP 04/30/2024 - UDI on ship case: 50885380031760; UDI on Dispenser carton: 20885380031769; UDI on individual unit: 10885380031762 2) 2D72PT65X, Lot Number TS21050215, EXP 04/30/2024 - UDI on ship case: 50885380031937, UDI on Dispenser carton: 20885380031936; UDI on individual unit: 10885380031939

Why it was recalled

Product was distributed without being sterilized.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

A recall letter dated 03/16/2022 was distributed to impacted consignees. The letter informs consignees that a portion of the distributed lots were distributed without undergoing sterilization. Customers should review their inventory for the impacted lots, segregate and quarantine all affected product, complete the acknowledgement form and return to Cardinal Health. Any customers who may have received further distributed product should be contacted and provided the recall information.

Recalling firm

Firm

Cardinal Health 200, LLC

Address

3651 Birchwood Dr, Waukegan, Illinois 60085-8337

Distribution

Distribution pattern

Product distributed throughout United States and Guam

Timeline

Recall initiated

2022-03-15

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #192652. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.