Drug recall
KimVent Closed Suction System for Adults, Double Swivel Elbow, 12 Fr., Sterile, Distributed by Kimberly Clark…
FDA recall event 70397 · Class II · Halyard Health
Key facts
| Event ID | 70397 |
|---|---|
| Recall numbers | Z-1220-2015, Z-1221-2015, Z-1222-2015 |
| Recalling firm | Halyard Health |
| Product type | Devices |
| Products | KimVent Closed Suction System for Adults, Double Swivel Elbow, 12 Fr., Sterile, Distributed by Kimberly Clark Global Systems, LLC., KimVent Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC., KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Defect: A hole or crack was found which may cause air to leak. |
| Initiation date | Jan 16, 2015 |
| Report date | Mar 11, 2015 |
| Termination date | Jul 7, 2015 |
| City | Roswell |
| State | GA |
| Country | United States |
| FEI number | 3011157493 |
At a glance
- 1–9 Products in this recall
- None 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: