FDA-Device2017-06-21Class II
Best Practice Kit, Item Numbers: 00Z2064, 00Z2150, 00Z2190, 00Z2192, 00Z2211, 00Z2212, 00Z2216, 00Z2217, 00Z2312
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
Best Practice Kit, Item Numbers: 00Z2064, 00Z2150, 00Z2190, 00Z2192, 00Z2211, 00Z2212, 00Z2216, 00Z2217, 00Z2312
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2545-2017Don't want to check this manually?
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