Recalls / —

—#214813

Product

GENERAL ROBOTIC PACK. Medical convenience kit.

FDA product code

OKV — Obstetrical Kit

Device class

Class 2

Medical specialty

Obstetrics/Gynecology

Affected lot / code info

Model No. NAFB082-04, NAMC473-01; UDI: 10809160395691, 10809160375037; Kit Lot No. 1568211, 1576237, 1599515, 1599516, 1605944, 1613558, 1616420, 1613626, 1625831, 1627259, 1628672, 1632042, 1635911.

Why it was recalled

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Consignees were sent an URGENT: MEDICAL DEVICE FIELD CORRECTION notice, dated 6/11/25, via email. The notification instructs consignees to not use the CLEARIFY Visualization System (component #5303907) and discard. All other components in the kit may be continued to be used. Consignees are to add warning labels to affected procedure trays to ensure the affected component is discarded. The provided Recall Response Form is to be completed and returned to Owens&Minor. Any quality problems or adverse events associated with recalled devices may be reported via email to complaints@owens-minor.com

Recalling firm

Firm

AVID Medical, Inc.

Address

9000 Westmont Dr, Toano, Virginia 23168-9351

Distribution

Distribution pattern

Domestic: CA, IL, MD, OH, PA, TX, WA.

Timeline

Recall initiated

2025-06-11

Posted by FDA

2025-08-04

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #214813. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.