Device recall: Vygon VY(TM)Flush Heparin Lock Flush Syringes, 1 Unit per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box…
Class II FDA enforcement event 61945. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Vygon Corporation started this device recall on 11 May 2012. The firm address in the FDA record is in Montgomeryville, PA. FDA put the recall in Class II. FDA event 61945 has 12 product records. The first FDA enforcement report date is 20 Jun 2012. The record gives the status Terminated, with the termination date 11 Mar 2013.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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.
Recalling firm
Vygon Corporation, Montgomeryville, PA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
12 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1797-2012 | 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 | Class II | Terminated | 20 Jun 2012 | |
| Z-1798-2012 | 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 | Class II | Terminated | 20 Jun 2012 | |
| Z-1799-2012 | 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 | Class II | Terminated | 20 Jun 2012 | |
| Z-1800-2012 | 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 | Class II | Terminated | 20 Jun 2012 | |
| Z-1801-2012 | 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 | Class II | Terminated | 20 Jun 2012 | |
| Z-1802-2012 | 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 | Class II | Terminated | 20 Jun 2012 | |
| Z-1803-2012 | 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 | Class II | Terminated | 20 Jun 2012 | |
| Z-1804-2012 | 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 | Class II | Terminated | 20 Jun 2012 | |
| 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 | Class II | Terminated | 20 Jun 2012 | |
| Z-1806-2012 | Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens | Class II | Terminated | 20 Jun 2012 | |
| Z-1807-2012 | Churchill Medical Systems, Inc. DRESSING CHANGE KIT Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens | Class II | Terminated | 20 Jun 2012 | |
| Z-1808-2012 | 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 | Class II | Terminated | 20 Jun 2012 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2012
- 823
- Share of these events in Class II
- 88%
- Product records in this event
- 12Median of the firm: 1
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 28 Aug 2014 | Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting | Device | Class II | 1 |
| 17 Dec 2012 | Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Component | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-1797-2012The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 61945. https://recallregister.com/fda/ii/61945/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
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.
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2012 have the same class?
- 88% of the 823 device events that started in 2012 are in Class II.
- How many FDA recalls does Vygon Corporation have?
- Vygon Corporation is the recalling firm in 3 enforcement events on this register. This event is 1 of them.