Z-1799-2024Class II
Medtronic Vessel Cannulae: a) DLP 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DLP 3 mm Vessel...
Medtronic Perfusion Systems / initiated 2024-03-19 / Open, Classified / root cause: manufacturing process
Medtronic Perfusion Systems began a recall of Medtronic Vessel Cannulae: a) DLP 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DLP 3 mm Vessel Cannula Blunt Tip, Model Number 30003 on . FDA classified it as Class II and gives the reason as "Potential for unsealed sterile packing". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1799-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Medtronic Perfusion Systems
- Product
- Medtronic Vessel Cannulae: a) DLP 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DLP 3 mm Vessel Cannula Blunt Tip, Model Number 30003
- Product code
- DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- Reason for recall
- Potential for unsealed sterile packing.
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- Medtronic issued an Urgent Medical Device Recall notice to its consignees on 03/19/2024 via letter (UPS). The notice explained the issue, potential risk, and requested the consignee identify and return the product. Consignee was directed to forward the notice to all affected parties. For questions, the consignee was directed to contact their Medtronic field representative.
- Quantity in commerce
- 5719 units
- Distribution
- Worldwide distribution.
- Product codes and lots
- a) Model Number 30004, GTIN 00613994646156, Lot Numbers: 2023041305; a) Model Number 30004, GTIN 00673978179841, Lot Numbers: 2023041300; a) Model Number 30004, GTIN 20613994646150, Lot Numbers: 2023041300, 2023041305, 202306C194; b) Model Number 30003, GTIN 20613994646174, Lot Numbers: 2023041298, 202306C221
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1793-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1794-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1795-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1796-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1797-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1798-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1799-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1800-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1801-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1802-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1803-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1804-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1805-2024 | Class II | Ongoing | Voluntary: Firm initiated |
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