—#209526

Product

Medline convenience kits containing semi-rigid suction liners labeled as follows: a) MINOR PROCEDURE, Pack Number CDS981509C; b) GENERAL LAPAROSCOPY CDS, Pack Number CDS981512J; c) OR MAJOR CDS, Pack Number CDS981515D; d) MAJOR-LF, Pack Number DYNJ900709C; e) MAJOR-LF, Pack Number DYNJ900709D; f) GENERAL LAPAROSCOPY-LF, Pack Number DYNJ900723C; g) GENERAL LAPAROSCOPY-LF, Pack Number DYNJ900723D; h) CYSTO, Pack Number DYNJ908098A; i) MINOR LAPAROTOMY, Pack Number DYNJ908428; j) MERCY TIFFIN BASIC LAP-LF, Pack Number DYNJ909730

FDA product code: FDE — Laparoscopy Kit
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: a) CDS981509C: UDI/DI case 40195327071173, UDI/DI each 10195327071172, Lot Numbers: 24ABS277; b) CDS981512J: UDI/DI case 4019532759782610195327597825, Lot Numbers: 24BBP412; c) CDS981515D: UDI/DI case 4019532707196810195327071967, Lot Numbers: 23KDC374, 24CDB523, 24EDA579; d) DYNJ900709C: UDI/DI case 4019348995099210193489950991, Lot Numbers: 23LBU953; e) DYNJ900709D: UDI/DI case 4019532763531310195327635312, Lot Numbers: 24CBQ684; f) DYNJ900723C: UDI/DI case 4019348995162310193489951622, Lot Numbers: 24ABL637; g) DYNJ900723D: UDI/DI case 4019532763534410195327635343, Lot Numbers: 24CBG030, 24CBO759, 24EBJ696; h) DYNJ908098A: UDI/DI case 4019532750725210195327507251, Lot Numbers: 24ABY035; i) DYNJ908428: UDI/DI case 4019532707116610195327071165, Lot Numbers: 24ABK094; j) DYNJ909730: UDI/DI case 4019532746453110195327464530, Lot Numbers: 24CBS071, 24EBI597

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 #209526. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.