—#209528

Product

Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1350D; b) ENDO KIT, Pack Number DYKE1514B

FDA product code: PPB — Foley Catheter Kit (Excludes Hiv Testing)
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: a) DYKE1350D: UDI/DI case 40193489339797, UDI.DI each 10193489339796; Lot Numbers: 24CBG448, 24EBF166; b) DYKE1514B: UDI/DI case 40193489797832, UDI.DI each 10193489797831; Lot Numbers: 24CBR722, 24FBA408

Why it was recalled

Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.

Root cause (FDA determination)

Process control

Action the firm took

Medline Industries issued a MEDICAL DEVICE RECALL notice to its consignees on 06/27/2024 via US mail and email. The notice explained the problem with the device, potential risk to the patient, and requested the consignee immediately check their stock for the affected item number and the affected lot numbers and destroy any affected inventory. Distributors were directed to notify their customers of the recall and request the affected products be destroyed. For questions: contact the Recall Department at 866-359-1704 or recalls@medline.com.

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.

Timeline

Recall initiated: 2024-06-27
Posted by FDA: 2024-09-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209528. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.