Z-2758-2024Class II
Medline procedural kits labeled as: 1) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B; 2) MERCY MEDICAL...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-04-08 / Open, Classified
MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline procedural kits labeled as: 1) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B; 2) MERCY MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 3) NURSERY... 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-2758-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline procedural kits labeled as: 1) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B; 2) MERCY MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 3) NURSERY CIRCUMCISION TRAY, Pack Number CIT4845; 4) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865; 5) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497
- Product code
- PWY Lumbar Puncture Tray (Adult & Pediatric)
- 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
- SPEC0300B, Lot Number 2022033050; CIT6780, Lot Number 2022042550; CIT4845, Lot Number 2022032450; MNS9865, Lot Number 2022021850; MNS9865, Lot Number 2022041850; DYNDA2497, Lot Number 2022042650
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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