Z-2745-2024Class II
Medline procedural kits labeled as: 1) CAROTID ENDARTERECTOMY PK, Pack Number DYNJ85516; 2) PICC INSERTION...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-04-08 / Open, Classified
MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline procedural kits labeled as: 1) CAROTID ENDARTERECTOMY PK, Pack Number DYNJ85516; 2) PICC INSERTION TRAY W/O CATH, Pack Number PICCNC0004; 3) VASCATH... 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-2745-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline procedural kits labeled as: 1) CAROTID ENDARTERECTOMY PK, Pack Number DYNJ85516; 2) PICC INSERTION TRAY W/O CATH, Pack Number PICCNC0004; 3) VASCATH INSERTION PACK, Pack Number, CVI4825
- 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 04/08/2024 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. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods.
- Distribution
- Worldwide
- Product codes and lots
- DYNJ85516, Lot Number 23JBI659 ; DYNJ85516, Lot Number 23LBE170 ; DYNJ85516, Lot Number 23LBR472 ; PICCNC0004 , Lot Number 23JMG079 ; CVI4825, Lot Number 22FLA595 ; CVI4825, Lot Number 22JLA721 ; CVI4825, Lot Number 22JLB203 ; CVI4825, Lot Number 22KLA852
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2739-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2740-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2741-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2742-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2743-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2744-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2745-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2746-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2747-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2748-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2749-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2750-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2751-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2752-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2753-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2754-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2755-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2756-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2757-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2758-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2759-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2760-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2761-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2762-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2763-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2764-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2765-2024 | Class II | Ongoing | Voluntary: Firm initiated |
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