Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the endotracheal tub
FDA device recall Z-1641-2014 · posted 2014-06-11 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- One lot of 3.0mm sized Connectors, Product Reorder No. 10035-05PS, Lot No. 2553426 were placed in packages labeled as size 3.5mm.
- Action taken
- Smiths Medical sent an Urgent Medical Device Recall Notice dated April 10, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory and quarantine all affected products and to complete the attached Response Form and return it to Smith Medical within 7 days of receipt of the notice. Customers with questions were instructed to contact Smiths Medical's Customer Service Department at +1-800-258-5361.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- BTR
- Quantity affected
- 100 devices
- Distribution
- US distribution in the state of North Carolina.
- Date initiated
- 2014-04-10
- Date posted
- 2014-06-11
- Date terminated
- 2016-11-29
- Location
- Keene, NH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENDOTRACHEAL TUBE W/HOLDER & CONNECTOR (K790312) | Respiratory Support Products, Inc. | 1979-02-21 |