Z-1449-2025Class II
Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Number DYNJ0665086F; 2) MAJOR VAGINAL...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-02-11 / Open, Classified
MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Number DYNJ0665086F; 2) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D; 3)... on . FDA classified it as Class II and gives the reason as "Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-1449-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Number DYNJ0665086F; 2) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D; 3) ROBOT LAP TOTAL HYST, Pack Number DYNJ907811A; 4) VAG HYSTE PACK-LF, Pack Number DYNJ0773613J; 5) VAG HYSTERECTOMY PACK-LF, Pack Number DYNJ0549338Q
- Product code
- OJF Hysterectomy Kit
- Reason for recall
- Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
- FDA root cause
- Under Investigation by firm
- Action
- Medline Industries LP issued a recall notice to its consignees on 02/11/2025 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request the syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. This is an expansion of RES 94583
- Quantity in commerce
- 268 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Product codes and lots
- 1) Pack Number DYNJ0665086F: UDI/DI 10193489395204 (each) 40193489395205 (case), Lot Number 23JBW085A; 2) Pack Number DYNJ0161768D: UDI/DI 10195327107499 (each) 40195327107490 (case), Lot Number 22CDB491A; 3) Pack Number DYNJ907811A: UDI/DI 10193489984170 (each) 40193489984171 (case), Lot Number 21IBP928Z; 4) Pack Number DYNJ0773613J: UDI/DI 10193489863918 (each) 40193489863919 (case), Lot Number 21GMA889A; 5) Pack Number DYNJ0549338Q: UDI/DI 10195327092139 (each) 40195327092130 (case), Lot Number 23EMD924A
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1435-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1436-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1437-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1438-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1439-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1440-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1441-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1442-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1443-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1444-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1445-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1446-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1447-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1448-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1449-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1450-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1451-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1452-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1453-2025 | Class II | Ongoing | Voluntary: Firm initiated |
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