FDAFDA · Food and drugs·Recall number Z-2544-2017
Sutures. BIOSYN: BIOSYN 4/0 18" VIOLET CV-25 DT, Item Number: GMJ34M
Published June 21, 2017 · Recall initiated: May 3, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic
- Distributor
- Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.
- Lot
- BIOSYN* 4/0 18" VIOLET CV-25 DT D4K0010X
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.