Dimequip
6 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (6)
Devices registered here (1)
- Catheters, Suction, TracheobronchialProduct code BSY (opens in a new tab) · Class I · Anesthesiology · 21 CFR 868.6810
Recalls & enforcement
- Class IIOngoing2021-04-15Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection
- Class IITerminated2018-12-06DualStop Caps defect causing leaks in affected product
- Class IITerminated2018-02-28Potential friction holes may affect the sterility of the product.
- Class IITerminated2014-08-28Vygon has uncovered potential problems with membrane elasticity in the 896.038, Bionector Needleless connector and is issuing a voluntary recall of the 896.038, Bionector Needleless connector.
- Class IITerminated2012-12-17Product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle.
- Class IITerminated2012-05-11Manufacturer 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.
Related
- All facilities operated by VYGON S A
- Vygon Verneuil (FR)
- VYGON S A (FR)
- SIPA (FR)
- VYGON Germany GmbH (DE)
- VYGON COLOMBIA S.A. (CO)
- Vygon Portugal (PT)
- SAP (FR)
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Dimequip (FEI 3002808467) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002808467-dimequip/
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