Z-1450-2025Class II
Medline procedure kits labeled as: 1) L S GYN PACK, Pack Number DYNJ65616C; 2) MAIN CYSTO, Pack Number...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-02-11 / Open, Classified
MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline procedure kits labeled as: 1) L S GYN PACK, Pack Number DYNJ65616C; 2) MAIN CYSTO, Pack Number DYNJ61371A; 3) OB PACK-LF, Pack Number DYNJ20720C; 4)... 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-1450-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline procedure kits labeled as: 1) L S GYN PACK, Pack Number DYNJ65616C; 2) MAIN CYSTO, Pack Number DYNJ61371A; 3) OB PACK-LF, Pack Number DYNJ20720C; 4) PELVISCOPY PACK-LF, Pack Number DYNJ0415776N; 5) POSTERIOR EYE PACK-LF, Pack Number PHS656483I; 6) ROBOTICS PACK-LF, Pack Number DYNJ0046667A
- Product code
- OKV Obstetrical 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
- 570 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Product codes and lots
- 1) Pack Number DYNJ65616C: UDI/DI 10195327470869 (each) 40195327470860 (case), Lot Number 23LMF217A; 2) Pack Number DYNJ61371A: UDI/DI 10193489796803 (each) 40193489796804 (case), Lot Number 21FMA140A; 3) Pack Number DYNJ20720C: UDI/DI 10884389620564 (each) 40884389620565 (case), Lot Number 21EMF438A; 4) Pack Number DYNJ0415776N: UDI/DI 10193489413984 (each) 40193489413985 (case), Lot Number 22CMD073A; 5) Pack Number PHS656483I: UDI/DI 10889942806768 (each) 40889942806769 (case), Lot Number 23GMB728A; 6) Pack Number DYNJ0046667A: UDI/DI 10889942160396 (each) 40889942160397 (case), Lot Number 22CMD979A
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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