Dénomination commerciale
Dispositifs médicaux de classe I des gammes CADD, Snuggle Warm, Portex, BCI, Medex, Jelco, Bivona (Smiths Medical_ICU Medical) : cf liste ci-dessous des dispositifs concernés
Fabricant
Smiths Medical ASD, Inc – Groupe ICU Medical
Distributeur(s) en France
Smiths Medical France – Groupe ICU Medical
Classe de risque du dispositif
classe I
Observations particulières
- Point d’attention sur les couvertures pour réchauffeurs à air pulsé Level 1 Snuggle Warm qui sont des consommables captifs des réchauffeurs à air pulsé de la marque Level 1, modèles Equator et L1CW
Références concernées par la rupture
CADD
| Famille de Produit | Code article | Description |
| Ambulatory Infusion Pumps | 21-2135-25 | CADD-Solis Polemount Adapter |
| Ambulatory Infusion Pumps | 21-2165-64 | CADD-Legacy Duodopa Pouch |
| Ambulatory Infusion Pumps | 21-2166-24 | CADD Pump Pouch |
| Ambulatory Infusion Pumps | 21-2167-25 | CADD Pump Pouch |
| Ambulatory Infusion Pumps | 21-2168-25 | CADD Pump Pouch |
| Ambulatory Infusion Pumps | 21-2169-24 | CADD Pump Pouch |
| Ambulatory Infusion Pumps | 21-2170-64 | CADD-Legacy Duodopa Pouch |
| Ambulatory Infusion Pumps | 21-2171-25 | CADD Pump Pouch, Single Use |
| Ambulatory Infusion Pumps | 21-2183-25 | CADD-Solis Polemount Swivel |
| Ambulatory Infusion Pumps | 21-2188-25 | CADD-Solis - LockBox |
| Ambulatory Infusion Pumps | 21-2189-25 | CADD-Solis - LockBox |
| Ambulatory Infusion Pumps | 21-6118-24 | CADD Polemount Bracket |
| Ambulatory Infusion Pumps | 21-6120-24 | CADD Lockable Polemount Bracket |
| Ambulatory Infusion Pumps | 21-6220-64 | CADD-Legacy Remote Dose |
Snuggle Warm
| Famille de Produit | Code article | Description |
| Convective Warming | SWU-2001 | Level 1 Snuggle Warm Convective Warming Blanket |
| Convective Warming | SWU-2002 | Level 1 Snuggle Warm Convective Warming Blanket |
| Convective Warming | SWU-2003 | Level 1 Snuggle Warm Convective Warming Blanket |
| Convective Warming | SWU-2004 | Level 1 Snuggle Warm Convective Warming Blanket |
| Convective Warming | SWU-2007 | Level 1 Snuggle Warm Convective Warming Blanket |
| Convective Warming | SWU-2009 | Level 1 Snuggle Warm Convective Warming Blanket |
| Convective Warming | SWU-2010 | Level 1 Snuggle Warm Convective Warming Blanket |
| Convective Warming | SWU-2011 | Level 1 Snuggle Warm Convective Warming Blanket |
| Convective Warming | SWU-2013 | Level 1 Snuggle Warm Convective Warming Blanket |
| Convective Warming | SWU-2014L | Level 1 Snuggle Warm Convective Warming Blanket |
| Convective Warming | SWU-2014R | Level 1 Snuggle Warm Convective Warming Blanket |
| Convective Warming | SWU-2016 | Level 1 Snuggle Warm Convective Warming Blanket |
| Convective Warming | SWU-2018 | Level 1 Snuggle Warm Convective Warming Blanket |
| Convective Warming | SWU-2113 | Level 1 Snuggle Warm Convective Warming Blanket |
| Convective Warming | SWU-2119 | Level 1 Snuggle Warm Convective Warming Blanket |
| Convective Warming | SWU-9002 | Snuggle Warm Hose Adapter |
| Convective Warming | SWU-9004 | Snuggle Warm Hose Adapter |
Portex
| Famille de Produit | Code article | Description |
| Intubation | 100/503/200 | Portex Tracheostomy Tube Holder - Non-Sterile |
BCI
| Famille de Produit | Code article | Description |
| Patient Monitoring | 1179 | BCI CO2 Absorber |
| Patient Monitoring | 8044 | BCI Sample Lines Extension |
| Patient Monitoring | 9048 | BCI Filter |
| Patient Monitoring | WW1018Y | BCI SPECTRO2 Oximeter Protective Gloves |
Medex
| Famille de Produit | Code article | Description |
| Pressure Monitoring | MX1821-BCZ | Medex C-Fusor Pressure Infusion - Squeeze Bulb Assembly |
| Pressure Monitoring | MX1821-GCZ | Medex C-Fusor Pressure Infusion - Gauge |
| Pressure Monitoring | MX240P1CZ | Medex Pressure Monitoring Manifold Clamp |
| Pressure Monitoring | MX257C2CZ | Medex TranStar Bracket |
| Pressure Monitoring | MX260CZ | Medex LogiCal Bracket |
| Pressure Monitoring | MX260-PMCZ | Medex LogiCal Patient Mount |
| Pressure Monitoring | MX261P1CZ | Medex LogiCal Bracket |
| Pressure Monitoring | MX262P1CZ | Medex LogiCal Bracket |
| Pressure Monitoring | MX264CZ | Medex LogiCal Bracket |
| Pressure Monitoring | MX267C2CZ | Medex LogiCal Bracket |
| Pressure Monitoring | MX4705P1CZ | Medex Clear-Cuff Pressure Infusor Bags |
| Pressure Monitoring | MX4710P1CZ | Medex Clear-Cuff Pressure Infusor Bags |
| Pressure Monitoring | MX4805P1CZ | Medex C-Fusor Pressure Infusion Devices |
| Pressure Monitoring | MX4806CZ | Medex C-Fusor Pressure Infusion Devices |
| Pressure Monitoring | MX4810P1CZ | Medex C-Fusor Pressure Infusion Devices |
| Pressure Monitoring | MX4830P1CZ | Medex C-Fusor Pressure Infusion Devices |
| Pressure Monitoring | MX800P1CZ | Medex Pressure Monitoring Transducer Plate |
| Pressure Monitoring | MX800-SCZ | Medex Novastrap |
| Pressure Monitoring | MX961Y08 | Medex Logical Pressure Monitoring Cable |
| Pressure Monitoring | MX961Y118CZ | Medex Logical Pressure Monitoring Cable |
| Pressure Monitoring | MX961Y132CZ | Medex Logical Pressure Monitoring Cable |
| Pressure Monitoring | MX961Y80CZ | Medex Logical Pressure Monitoring Cable |
| Pressure Monitoring | MX961Z03P1CZ | Medex Logical Pressure Monitoring Cable |
| Pressure Monitoring | MX961Z04P1CZ | Medex Logical Pressure Monitoring Cable |
| Pressure Monitoring | MX961Z14P1CZ | Medex Logical Pressure Monitoring Cable |
| Pressure Monitoring | MX961Z15P1CZ | Medex Logical Pressure Monitoring Cable |
| Pressure Monitoring | MX961Z22P1CZ | Medex Logical Pressure Monitoring Cable |
| Pressure Monitoring | MX961Z42P1CZ | Medex Logical Pressure Monitoring Cable |
| Pressure Monitoring | MX961Z50P1CZ | Medex Logical Pressure Monitoring Cable |
| Pressure Monitoring | MX961Z68P1CZ | Medex Logical Pressure Monitoring Cable |
| Pressure Monitoring | MX961Z74P1 | Medex Logical Pressure Monitoring Cable |
| Pressure Monitoring | MX962Z02P1 | Medex Logical Pressure Monitoring Cable |
| Pressure Monitoring | MX962Z42P1CZ | Medex Logical Pressure Monitoring Cable |
| Pressure Monitoring | MX962Z68P1CZ | Medex Logical Pressure Monitoring Cable |
| Pressure Monitoring | MX980-02CZ | Medex TranStar Pressure Monitoring Cable |
| Pressure Monitoring | MX980-20CZ | Medex TranStar Pressure Monitoring Cable |
| Pressure Monitoring | MX980-42CZ | Medex TranStar Pressure Monitoring Cable |
| Pressure Monitoring | MX981-22CZ | Medex TranStar Pressure Monitoring Cable |
| Pressure Monitoring | MX981-68CZ | Medex TranStar Pressure Monitoring Cable |
Jelco
| Famille de Produit | Code article | Description |
| Sharps Safety | 4139 | Jelco Point-Lok Sharps Safety Device |
| Sharps Safety | 4140 | Jelco Venipuncture Needle-Pro Needle Protection Device |
| Sharps Safety | 4141 | Jelco Venipuncture Needle-Pro Needle Protection Device |
| Sharps Safety | 4142 | Jelco Venipuncture Needle-Pro Needle Protection Device |
Portex
| Famille de Produit | Code article | Description |
| Tracheostomy | 100/555/100 | Portex Tracheostomy Wedge |
| Tracheostomy | 100/855/000CZ | Portex Blue Line Ultra Cleaning Brush |
Bivona
| Famille de Produit | Code article | Description |
| Tracheostomy | CON15S | Bivona Side Port Auto Control Airway Connector |
| Tracheostomy | REDCAP | Bivona Tracheostomy Universal 15mm Redcap Plugs |