Drug recall
KimVent* Closed Suction System for Adults, 12 F, Elbow (Product Code 216); KimVent* Closed Suction KimVent*…
FDA recall event 71966 · Class II · Halyard Health, Inc
Key facts
| Event ID | 71966 |
|---|---|
| Recall numbers | Z-2492-2015, Z-2493-2015, Z-2494-2015, Z-2495-2015, Z-2496-2015, Z-2497-2015, Z-2498-2015, Z-2499-2015, Z-2500-2015, Z-2501-2015, Z-2502-2015, Z-2503-2015 and 20 more |
| Recalling firm | Halyard Health, Inc |
| Product type | Devices |
| Products | KimVent* Closed Suction System for Adults, 12 F, Elbow (Product Code 216); KimVent* Closed Suction KimVent* Closed Suction System for Adults, 14 F, Elbow (Product Code 221); KimVent* Closed Suction…, KimVent* Closed Suction System for Adults, 12 F, T-Piece,12 in Tracheostomy (Product Code 215135); KimVent* Closed Suction System for Adults, 12 F, T-Piece, 12 in Trach (Product Code 21513511) A…, KimVent* Closed Suction System for Adults, 12 F, T-Piece (Product Code 2155); KimVent* Closed Suction System for Adults, 14 F, T-Piece (Product Code 2205, 8169, 8248, 22015, 22025, 220125, 220135) A…, KimVent* Closed Suction System for Adults, 14 F, DSE, DT (Product Code 22109) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to…, KimVent* Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 22108); KimVent* Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 221038) A tracheobronchial suction catheter is a… and 27 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position. |
| Initiation date | Jul 29, 2015 |
| Report date | Sep 9, 2015 |
| Termination date | Jan 12, 2016 |
| City | Alpharetta |
| State | GA |
| Country | United States |
| FEI number | 3011270181 |
At a glance
- 10–99 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: