510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-2711-2024Class II

Medline medical procedure kits labeled as follows: a) BASIC NEURO, REF DYNJ909171A; b) NEURO, REF...

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-03-22 / Open, Classified
FDA source (opens on fda.gov)

MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline medical procedure kits labeled as follows: a) BASIC NEURO, REF DYNJ909171A; b) NEURO, REF DYNJ905510D; c) NEURO, REF DYNJ902388L; d) NEURO SAS, REF... on . FDA classified it as Class II and gives the reason as "A slight dimensional variation which has the potential for increased difficulty fitting into outer canister". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-2711-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
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
Product code
OJG Neurological Tray
Reason for recall
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
FDA root cause
Under Investigation by firm
Action
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.
Quantity in commerce
2013 units
Distribution
Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
Product codes and lots
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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2711-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2694-2024Class IIOngoingVoluntary: Firm initiated
Z-2695-2024Class IIOngoingVoluntary: Firm initiated
Z-2696-2024Class IIOngoingVoluntary: Firm initiated
Z-2697-2024Class IIOngoingVoluntary: Firm initiated
Z-2698-2024Class IIOngoingVoluntary: Firm initiated
Z-2699-2024Class IIOngoingVoluntary: Firm initiated
Z-2700-2024Class IIOngoingVoluntary: Firm initiated
Z-2701-2024Class IIOngoingVoluntary: Firm initiated
Z-2702-2024Class IIOngoingVoluntary: Firm initiated
Z-2703-2024Class IIOngoingVoluntary: Firm initiated
Z-2704-2024Class IIOngoingVoluntary: Firm initiated
Z-2705-2024Class IIOngoingVoluntary: Firm initiated
Z-2706-2024Class IIOngoingVoluntary: Firm initiated
Z-2707-2024Class IIOngoingVoluntary: Firm initiated
Z-2708-2024Class IIOngoingVoluntary: Firm initiated
Z-2709-2024Class IIOngoingVoluntary: Firm initiated
Z-2710-2024Class IIOngoingVoluntary: Firm initiated
Z-2711-2024Class IIOngoingVoluntary: Firm initiated
Z-2712-2024Class IIOngoingVoluntary: Firm initiated
Z-2713-2024Class IIOngoingVoluntary: Firm initiated
Z-2714-2024Class IIOngoingVoluntary: Firm initiated