smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as foll
FDA device recall Z-3088-2024 · posted 2024-09-11 · Open, Classified
Recall details
- Recalling firm
- Smiths Medical ASD Inc.
- Reason for recall
- 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.
- Action taken
- 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
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- BTO
- Quantity affected
- 41691 units
- Distribution
- Worldwide
- Date initiated
- 2024-06-07
- Date posted
- 2024-09-11
- Location
- Minneapolis, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube (K173384) | Smiths Medical Ads, Inc. | 2018-04-10 |