—#207022

Product

Medline medical procedure kits labeled as follows: a) BASIC NEURO, REF DYNJ909171A; b) NEURO, REF DYNJ905510D; c) NEURO, REF DYNJ902388L; d) NEURO SAS, REF DYNJ908566

FDA product code: OJG — Neurological Tray
Device class: Class 1
Medical specialty: Neurology
Affected lot / code info: a) REF DYNJ909171A, UDI/DI 40195327384570 (case), 10195327384579 (unit), Lot Numbers: 23ELA235, 23ELA709, 23FLA843, 23FLB029, 23ILA269, 23JLA515, 23KLA152; b) REF DYNJ905510D, UDI/DI 40193489967495 (case), 10193489967494 (unit), Lot Numbers: 22FMD495, 22FME413, 22JMG896, 23CMA506, 23DMF104, 23DMG416, 23DMH216, 23FMB741, 23GMI014, 23LMC545; c) REF DYNJ902388L, UDI/DI 40195327505876 (case), 10195327505875 (unit), Lot Numbers: 23KBP772; d) REF DYNJ908566, UDI/DI 40195327086450 (case), 10195327086459 (unit), Lot Numbers: DYNJ908566, DYNJ908566, DYNJ908566, DYNJ908566, DYNJ908566, DYNJ908566, DYNJ908566, DYNJ908566, DYNJ908566, DYNJ908566, DYNJ908566, DYNJ908566, DYNJ908566

Why it was recalled

A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Medline Industries issued a Safety Alert to its consignees on 03/22/2024 via email and certified mail. The notice explained the problem with the device and requested that consignees follow the instructions for use. Distributors or those who further transferred the affected product were directed to notify their consignees.

Recalling firm

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

Distribution

Distribution pattern: Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.

Timeline

Recall initiated: 2024-03-22
Posted by FDA: 2024-08-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #207022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.