Recalls / —

—#215630

Product

Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit.

FDA product code

LRO — General Surgery Tray

Device class

Class 2

Medical specialty

General, Plastic Surgery

Affected lot / code info

Model Number: 1646381. UDI: 10809160363256. Lot Number: 1646381. Expiration Date: 1/31/2028.

Why it was recalled

Potential for open header bag seals, compromising sterility.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Owens & Minor notified consignees on about 08/04/2025 via email. Consignees were instructed to discard and discontinue use of all impacted kits. to notify customers if affected units were further distributed, and complete and return the Recall Response Form provided.

Recalling firm

Firm

AVID Medical, Inc.

Address

9000 Westmont Dr, Toano, Virginia 23168-9351

Distribution

Distribution pattern

US Nationwide distribution in the state of Florida.

Timeline

Recall initiated

2025-08-04

Posted by FDA

2025-09-05

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #215630. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.