Vital Signs 8001543

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number70885403255252 UDI-DI	Date14 Sep 2016Listed	StatusListed GUDID: not in commercial distribution

6 recalls · 1 ongoing · FDA

- Ongoing Z-1289-2025 FDA Class I initiated 13 Feb 2025
Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.
4 recalls, same reason
- Terminated Z-2538-2014 FDA Class I initiated 7 Jul 2014
- Terminated Z-2537-2014 FDA Class I initiated 7 Jul 2014
- Terminated Z-2539-2014 FDA Class I initiated 7 Jul 2014
- Terminated Z-2536-2014 FDA Class I initiated 7 Jul 2014
The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.
- Terminated Z-1641-2014 FDA Class I initiated 10 Apr 2014
One lot of 3.0mm sized Connectors, Product Reorder No. 10035-05PS, Lot No. 2553426 were placed in packages labeled as size 3.5mm.

1 jurisdiction

United States — GUDID listing Listed

GUDID