Device 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
Z-2711-2024
Product summary
- Event
- Event 94356
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2013 units
- Official record key
device-enforcement:Z-2711-2024
Official wording
Reason: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Code information: 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
Distribution pattern: Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
Derived failure modes
-
Unknown
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.