Z-1732-2020Class II
Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN: M0066703100...
Boston Scientific Corporation / initiated 2020-03-09 / Open, Classified
Boston Scientific began a recall of Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN: M0066703100 single unit on . FDA classified it as Class II and gives the reason as "An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-1732-2020
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Boston Scientific Corporation
- Product
- Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN: M0066703100 single unit
- Product code
- EZB Stylet For Catheter, Gastro-Urology
- Reason for recall
- An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
- FDA root cause
- Component change control
- Action
- Boston Scientific issued Customer Notification on March 9, 2020 stating reason for recall, health risk and action to take: cease distribution or use of any remaining product affected by this removal should cease immediately; Verify by product lot/batch number in the product table whether any product within your inventory is affected. If so, indicate on your Verification Form the quantity of units from each lot/batch that you will bereturning. As some of these products within these lots/batches are sold as 5-packs, it is important that all reported quantities represent the actual number of single units being returned and not the number of cartons/boxes or multi-packs; If you identify any product from the affected lots/batches within your inventory, please segregate the product immediately and return it to BSC in accordance with the enclosed instructions. If you are a distributor, please note that the depth is to the hospital level and this notification should be forwarded to your customers. If you are a facility that has sent products to another hospital within your network, please ensure that this notification is forwarded to them.
- Quantity in commerce
- 225
- Distribution
- Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan
- Product codes and lots
- Lot Numbers: 24538844, 24647121
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1729-2020 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1730-2020 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1731-2020 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1732-2020 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1733-2020 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1734-2020 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1735-2020 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1736-2020 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1737-2020 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1738-2020 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1739-2020 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1740-2020 | Class II | Ongoing | Voluntary: Firm initiated |
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