FDA Recall Completed

Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves

Recall: Z-0902-2022 · Initiated March 15, 2022

Recall

Recall Number
Z-0902-2022
Event Number
89832
Firm
Cardinal Health 200, LLC
FEI Number
3001236905
Product Code
KGO
Status
Completed
Root Cause
Under Investigation by firm
Initiated
March 15, 2022
Address
3651 Birchwood Dr, Waukegan, IL, 60085-8337

Description

Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves

Reason

Product was distributed without being sterilized.

Action

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.

Distribution

Product distributed throughout United States and Guam

Quantity

486,578 pairs