Vygon Mbs-2015
Vygon Mbs-2015 is a Class II device made by Vygon Corp., cleared under FDA 510(k) K873957 on 23 Oct 1987 and listed in FDA GUDID since 16 Aug 2016 (UDI-DI 08498840006832), active as of 23 Oct 2026. 2 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08498840006832 | Date16 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK873957 | Date23 Oct 1987 | StatusActive |
Official records
- AccessGUDID record 08498840006832
- FDA 510(k) database K873957
Across registries
- FDA 510(k) K873957 decided 23 Oct 1987 Active
- FDA GUDID UDI-DI 08498840006832 listed 16 Aug 2016 Listed
Recalls
-
- Terminated Z-0681-2018
Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging. This potential lack of adhesive may affect the sterility of the product.
-
- Terminated Z-1480-2012
Mislabeled: MBS-2210 code on case label -22Ga Winged Infusion Set, ; however, the product label states 20Ga MBS-2010 code listed on device label.
Timeline
- Cleared FDA 510(k) K873957
- Recall initiated FDA recalls Z-1480-2012
- Listed FDA GUDID 08498840006832
- Recall initiated FDA recalls Z-0681-2018
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Vygon
- Generic name
- Vascular port administration set
- Model / Ref / Catalog
- MBS-2015
- Primary DI / UDI-DI
- 08498840006832
- 510(k) Number
- FDA product code
- FMI
- GMDN term
- Vascular port administration set
- Device class
- Class II
- Regulation number
- 880.5570
- GUDID distribution status
- In Commercial Distribution
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