—#207507

Product

MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020

FDA product code: FMF — Syringe, Piston
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K061275
Affected lot / code info: UDI/DI 10080196306183, All lots in the format: 897YYMMXXXX

Why it was recalled

It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may pose a risk to patient health.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Medline Industries, LP, issued a recall notice to its consignees on 04/22/2024 via USPS first class mail. The notice explained the problem with the device, potential risk, and requested that the affected product be destroyed.

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 Canada, Panama, UAE, USVI.

Timeline

Recall initiated: 2024-04-22
Posted by FDA: 2024-05-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #207507. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.