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
This recall is currently active, issued August 22, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- March 22, 2024
- Posted
- August 22, 2024
- Recall Number
- Z-2711-2024
- Quantity
- 2013 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Distribution
Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
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
Root Cause
Under Investigation by firm
Action Taken
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.