—#202809

Product

MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049

FDA product code: JOK — Scissors, Medical, Disposable
Device class: Class 1
Medical specialty: General Hospital
Affected lot / code info: UDI/DI 10080196847273, all lots

Why it was recalled

4.5" Iris Scissors, Sterile, Curved (DYNJ04049) are being recalled due to the potential of the tip protector to fall off. The sharp tip of the scissors could compromise the sterile barrier system by puncturing large and/or small holes that may not be visible to the user.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Medline Industries issued a recall notice to its consignees by email on 08/03/2023. The notice explained the problem with the device, the potential hazard, and requested the following: Immediately check your stock for the affected item number and the affected lot numbers listed on the recall portal. Destroy affected product. Distributors or those who resold or transferred the product were directed to notify their customers and have them destroy any affected product. If you have any questions, please contact the Recall Department at 866-359-1704.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Canada, Hong Kong, Taiwan, Singapore

Timeline

Recall initiated: 2023-08-03
Posted by FDA: 2023-09-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #202809. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.