Drug recall
Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit Prefilled syringes included in the kit…
FDA recall event 61945 · Class II · Vygon Corporation
Key facts
| Event ID | 61945 |
|---|---|
| Recall numbers | Z-1797-2012, Z-1798-2012, Z-1799-2012, Z-1800-2012, Z-1801-2012, Z-1802-2012, Z-1803-2012, Z-1804-2012, Z-1805-2012, Z-1806-2012, Z-1807-2012, Z-1808-2012 |
| Recalling firm | Vygon Corporation |
| Product type | Devices |
| Products | Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens, Churchill Medical Systems, Inc. A VYGON COMPANY PICC INSERTION TRAY Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens, Churchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit Prefilled syringes included in the tray kit are used to maintain the patency of indwelling catheter lumens, Churchill Medical Systems, Inc. DRESSING CHANGE KIT Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens, Churchill Medical Systems, Inc. PORT-A-CATH Tray Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens and 6 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and… |
| Initiation date | May 11, 2012 |
| Report date | Jun 20, 2012 |
| Termination date | Mar 11, 2013 |
| City | Montgomeryville |
| State | PA |
| Country | United States |
| FEI number | 2245270 |
At a glance
- 10–99 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: