Drug recall
Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit contains: 1 Pair Nitrile Gloves…
FDA recall event 66060 · Class II · Churchill Medical Systems, Inc.
Key facts
| Event ID | 66060 |
|---|---|
| Recall numbers | Z-2251-2013, Z-2252-2013 |
| Recalling firm | Churchill Medical Systems, Inc. |
| Product type | Devices |
| Products | Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit contains: 1 Pair Nitrile Gloves W/Wallet, Powderfree 1 Face Mask 1 Polylined Drape, 13" X 18" 1 ChloraPrep***, 3ml…, Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Microbore tubing disconnecting from male luers on the extension sets. |
| Initiation date | Aug 12, 2013 |
| Report date | Sep 25, 2013 |
| Termination date | Jun 16, 2014 |
| City | Dover |
| State | NH |
| Country | United States |
| FEI number | 1000120555 |
At a glance
- 1–9 Products in this recall
- 1–9 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: