Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2024-2024Class II

MEDLINE STERILE IRIS SCISSORS CVD/STD REF DYNJ04049 (case) and DYNJ04049H (individual unit)

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-04-30 / Open, Classified / root cause: sterility

MEDLINE INDUSTRIES, LP - Northfield began a recall of MEDLINE STERILE IRIS SCISSORS CVD/STD REF DYNJ04049 (case) and DYNJ04049H (individual unit) on . FDA classified it as Class II and gives the reason as "There is the potential of the tip protector to fall off 4.5" sterile, curved, Iris Scissors". As of , the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number
Z-2024-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Product
MEDLINE STERILE IRIS SCISSORS CVD/STD REF DYNJ04049 (case) and DYNJ04049H (individual unit)
Product code
JOK Scissors, Medical, Disposable
Reason for recall
There is the potential of the tip protector to fall off 4.5" sterile, curved, Iris Scissors
Root cause tag
sterility
FDA root cause
Under Investigation by firm
Action
Medline Industries, LP issued a recall notice to its consignees on 04/30/2024 via email and USPS First Class Mail. The notice explained the issued, potential risk, and requested the product be destroyed. Those who further distributed the affected product were directed to notify those to whom the affected product was distributed.
Quantity in commerce
67811 units
Distribution
Worldwide distribution - US Nationwide and the countries of Singapore, Canada.
Product codes and lots
UDI/DI 10080196847273, Lot Numbers: 23GBV681, 23HBD138, 23IBF254, 23LBJ787

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2024-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2024-2024Class IIOngoingVoluntary: Firm initiated