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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2024-2024 | Class II | Ongoing | Voluntary: Firm initiated |
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