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FDA-Device2026-02-11Class II

Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25

Vortex Surgical Inc.
Hazard
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Sold states
Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.
Affected count
14,789 (8651 US; 6138 OUS)
Manufactured in
4 Research Park Dr Ste 124, N/A, Saint Charles, MO, United States
Products
Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1250-2026

Original summary

Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25 There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection. Pouch UDI 810123480456 Box UDI 810123480739 Lot 2410044 Distribution: Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam. Affected quantity: 14,789 (8651 US; 6138 OUS)

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