Enforcement Report - Week of June 20, 2012
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Event Detail
| Event ID | 61945 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Vygon Corporation |
| City | Montgomeryville |
| State | PA |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-05-11 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Vygon VY(TM)Flush Heparin Lock Flush Syringes, 1 Unit per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box Prefilled syringes are used to maintain the patency of indwelling catheter lumens | Product Code VIH-4423 -- lots 92-057-9D, 95-041-9D, 97-063-9D, and 92-155-9D. | Class II | 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 kits containing the syringes. | Z-1797-2012 | |
| Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens | Product Code VIH-2233 -- lots 87-133-9D, 93-088-9D, 97-066-9D, 00-015-9D, 03-012-9D, 03-113-9D, 03-116-9D, 08-067-9D, 08-071-9D, 95-027-9D, 95-029-9D, and 08-073-9D. | Class II | 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 kits containing the syringes. | Z-1798-2012 | |
| Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens | Product Code VIH-2235 -- lots 86-088-9D, 87-106-9D, 89-080-9D, 90-048-9D, 91-058-9D, 91-059-9D, 91-135-9D, 92-110-9D, 93-062-9D, 93-063-9D, 94-034-9D, 94-044-9D, 95-030-9D, 95-052-9D, 97-051-9D, 97-053-9D, 97-071-9D, and 97-083-9D. | Class II | 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 kits containing the syringes. | Z-1799-2012 | |
| Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens | Product Code VIH-3333 -- lots 91-036-9D, 92-079-9D, 97-040-9D, 99-130-9D, 01-005-9D, 01-062-9D, 01-063-9D, 03-082-9D, 07-046-9D, 08-060-9D, 95-070-9D, 96-006-9D, 94-010-9D, 97-040-9D, and 10-010-9D. | Class II | 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 kits containing the syringes. | Z-1800-2012 | |
| Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens | Product Code VIH-3335 -- lots 89-099-9D, 89-143-9D, 90-093-9D, 92-073-9D, 92-097-9D, 92-124-9D, 92-140-9D, 92-142-9D, 94-009-9D, 94-013-9D, 94-045-9D, 94-140-9D, 94-147-9D, 95-013-9D, 95-014-9D, 95-109-9D, 96-049-9D, 98-010-9D, 99-041-9D, 00-012-9D, 01-036-9D, 01-055-9D, 02-065-9D, 02-067-9D, 02-100-9D, 07-020-9D, 07-031-9D, 07-033-9D, 07-041-9D, 08-037-9D, 08-048-9D, 09-007-9D, 09-009-9D, 09-022-9D, 10-001-9D, 10-012-9D, 10-049-9D, 10-039-9D, 12-022-9D, and 12-026-9D. | Class II | 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 kits containing the syringes. | Z-1801-2012 | |
| 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 | Product Code AMS-9848CP-11 -- lots 10J80 and 10K62. | Class II | 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 kits containing the syringes. | Z-1802-2012 | |
| 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 | Product Code AMS-9889CP-7 -- lot 10I86. | Class II | 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 kits containing the syringes. | Z-1803-2012 | |
| 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 | Product Code AMS-8280CP-4 -- lots 10K16, 10L20, 11A78, 11B24, 11B16, 11C70, and 11D14. | Class II | 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 kits containing the syringes. | Z-1804-2012 | |
| Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens | Product Code AMS-8522CP-3 - lot 10K50. | Class II | 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 kits containing the syringes. | Z-1805-2012 | |
| Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens | Product Code AMS-9437CP -- lots 1112059, 1112106, 1202101, 1101505, 1101026, 1103020, 1104130, 1103190, and 1109064. | Class II | 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 kits containing the syringes. | Z-1806-2012 | |
| Churchill Medical Systems, Inc. DRESSING CHANGE KIT Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens | Product Code AMS-7091CP - lot 11C119. | Class II | 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 kits containing the syringes. | Z-1807-2012 | |
| 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 | Product Code AMS-8172CP-5 -- lots 10J15, 10K09, 10K19, 11A77, 11C103, 11D79, 11F66, 11H18, 11J41, and 11L54. | Class II | 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 kits containing the syringes. | Z-1808-2012 |
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