Z-2629-2024Class II
Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC INSERT BUNDLE 16CM, Pack...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-04-08 / Open, Classified / root cause: manufacturing process
MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260; 2) VANTEX 7FR 3L 20CM CVC BUNDLE US... 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, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2629-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260; 2) VANTEX 7FR 3L 20CM CVC BUNDLE US, Pack Number ECVC8045
- Product code
- OFG Ct Biopsy 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.
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- 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 these 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.
- Quantity in commerce
- 1,679,067 units in total
- Distribution
- Worldwide distribution.
- Product codes and lots
- 1) ECVC3260, Lot Number 2018052950; 2) ECVC8045, Lot Number 2023110290
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2623-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2624-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2625-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2626-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2627-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2628-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2629-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2630-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2631-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2632-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2633-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2634-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2635-2024 | Class II | Ongoing | Voluntary: Firm initiated |
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