FDA-Device2017-06-21Class II
Sutures. BIOSYN: BIOSYN 4/0 18" VIOLET CV-25 DT, Item Number: GMJ34M
Medtronic
Hazard
Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
Sold states
Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.
Affected count
478,465 (total for all products)
Manufactured in
60 Middletown Ave, N/A, North Haven, CT, United States
Products
Sutures. BIOSYN: BIOSYN 4/0 18" VIOLET CV-25 DT, Item Number: GMJ34M
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2544-2017Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief