Z-1439-2025Class II
Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O; 2) BARRINGTON ACCESSORY...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-02-11 / Open, Classified
MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O; 2) BARRINGTON ACCESSORY TTL KNEE, Pack Number DYNJ56717A; 3) CVL INSERTION... 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-1439-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O; 2) BARRINGTON ACCESSORY TTL KNEE, Pack Number DYNJ56717A; 3) CVL INSERTION PACK, Pack Number CVI5065; 4) KT DR VELASCO FISTULA PACK, Pack Number DYNJ46648D; 5) PICC ABSCESS PACK-LF, Pack Number DYNJ0774005G; 6) PICC/RAD SPEC PROC 0906165-LF, Pack Number DYNJ32773G; 7) VAP PACK-LF, Pack Number PHS656578F
- Product code
- OFF Central Venous Catheter Tray
- 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
- 398
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Product codes and lots
- 1) Pack Number DYNJ0826753O : UDI/DI 10193489384291 (each) 40193489384292 (case), Lot Number 23GMB253A; 2) Pack Number DYNJ56717A : UDI/DI 10889942897940 (each) 40889942897941 (case), Lot Number 21EBM603A; 3) Pack Number CVI5065 : UDI/DI 10195327504366 (each) 40195327504367 (case), Lot Number 23LMH242A; 4) Pack Number DYNJ46648D : UDI/DI 10193489755244 (each) 40193489755245 (case), Lot Number 20HMC528A; 5) Pack Number DYNJ0774005G : UDI/DI 10193489271485 (each) 40193489271486 (case), Lot Number 21EMA842Z; 6) Pack Number DYNJ32773G : UDI/DI 10193489766134 (each) 40193489766135 (case), Lot Number 21IMG907A; 7) Pack Number PHS656578F : UDI/DI 10889942804535 (each) 40889942804536 (case), Lot Number 20LKB006A
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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