Recalls / —

—#207231

Product

Centurion OB INSTRUMENT TRAY, REF MN3925; Medical procedure convenience tray

FDA product code

LRP — Tray, Surgical

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

UDI/DI 40653160122945 (case), 10653160122944 (unit), Lot Numbers: 23JBX257, 23KMG455

Why it was recalled

Trumpet Needle Guide ring can detach when excessive pressure is applied.

Root cause (FDA determination)

Process control

Action the firm took

Medline issued a correction notice to its consignees on 03/01/2024 via email and USPS first class mail. The notice explained the issue and requested the consignee identify and quarantine all affected products, and respond to the notice. Once the response was received Medline would provide labels to place over the affected product in stock. If the product was further distributed the party which distributed the product was directed to notify their customers.

Recalling firm

Firm

MEDLINE INDUSTRIES, LP Northfield

Address

3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern

US Nationwide distribution.

Timeline

Recall initiated

2024-03-01

Posted by FDA

2024-05-29

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #207231. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.