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Completed

Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves

FDA Recall Z-0902-2022 · Posted None

Recalling FirmCardinal Health 200, LLC
Recall StatusCompleted
Product CodeKGO
Date Initiated2022-03-15
Product Quantity486,578 pairs

Reason for Recall

Product was distributed without being sterilized.

Firm 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.

Root Cause

Under Investigation by firm

Distribution Pattern

Product distributed throughout United States and Guam

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110272STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGCardinal Health, Inc. · 2011-06-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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