Recalls / —

—#207616

Product

MEDLINE STERILE IRIS SCISSORS CVD/STD REF DYNJ04049 (case) and DYNJ04049H (individual unit)

FDA product code

JOK — Scissors, Medical, Disposable

Device class

Class 1

Medical specialty

General Hospital

Affected lot / code info

UDI/DI 10080196847273, Lot Numbers: 23GBV681, 23HBD138, 23IBF254, 23LBJ787

Why it was recalled

There is the potential of the tip protector to fall off 4.5" sterile, curved, Iris Scissors

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Medline Industries, LP issued a recall notice to its consignees on 04/30/2024 via email and USPS First Class Mail. The notice explained the issued, potential risk, and requested the product be destroyed. Those who further distributed the affected product were directed to notify those to whom the affected product was distributed.

Recalling firm

Firm

MEDLINE INDUSTRIES, LP Northfield

Address

3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Singapore, Canada.

Timeline

Recall initiated

2024-04-30

Posted by FDA

2024-06-06

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #207616. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.