Home › Movair, Inc. › Stableline Tubing Organizer (Non Sterile)
Stableline Tubing Organizer (Non Sterile)
Movair, Inc. · Model 5000N · UDI-DI 20814321020197
KRI
Prescription
10
510(k) clearances
17
Adverse events (1 deaths)
8
Recalls
44
Facilities
Description
The Stableline is designed to stabilize and contain one to six tubing lines of varying sizes which connect cardiopulmonary bypass equipment for delivery or return of fluids to and from the surgical field. The product attaches to the surgical drapes and prevents the tubing lines from slipping, while keeping them out of the way of appropriate procedures. This component is a disposable, single use item.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-06-27 | Maquet Cardiopulmonary Gmbh | Device does not comply with the labeling requirements of international standard IEC 60601-1. |
| 2020-06-18 | Maquet Cardiovascular Us Sales, Llc | Removal for a specific lot, lot number 70128207, of Holder HKHZ 19 for use with QUADROX iD Pediatric Oxygenator. The Holder may not always snap and securely hold the oxygenator as |
| 2018-04-04 | Maquet Cardiopulmonary Ag | There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations. |
| 2011-08-12 | Terumo Cardiovascular Systems Corporation | Level Sensor II mounting pads may not stick to the venous reservoir and may detach either at case setup or during a case. |
| 2011-03-01 | Terumo Cardiovascular Systems Corp | Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line |
| 2009-12-14 | Medtronic Inc | Medtronic has identified a small number of Autotransfusion One Source Kits and MAXPAC/Total System lots with incorrect Use Before Dates (UBD) on the outer kit package label. The U |
| 2009-12-14 | Medtronic Inc | Medtronic has identified a small number of Autotransfusion One Source Kits and MAXPAC/Total System lots with incorrect Use Before Dates (UBD) on the outer kit package label. The U |
| 2009-10-02 | Terumo Cardiovascular Systems Corporation | Backplate reservoir holders were manufactured with an incorrect configuration of connector supports. The devices were manufactured and configured with two 3/8 inch and one inch co |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.