Recall Z-3088-2024 ยท BTO Tube, Tracheostomy (W/Wo Connector)
Smiths Medical ASD Inc.
smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as follows: 1) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 7.0 mm BLUselect trach tube, Item Number 101/561/070; 2) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 8.0 mm BLUselect trach tube, Item Number 101/561/080; 3) BLUp
| Date | Sep 11, 2024 (initiated Jun 7, 2024) |
| Status | Open, Classified |
| Reason | There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUperc products due to a manufacturing defect. |
| Root cause | Process control |
| Action | Smiths Medical issued an URGENT MEDICAL DEVCIE NOTIFICATION to its consignees on 06/07/2024 via traceable mailing. The notice explained the issue with the device, potential risk to the patient, and requested the affected devices be discarded. Distributor were directed to forward the notice to their customers. For questions: Customer service: customerservice@icumed.com; 800-258-5361) Complaints: globalcomplaints@icumed.com; 866-216-8806 |
| Quantity | 41691 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173384 | BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dila Smiths Medical Ads, Inc., Apr 10, 2018 |