FDA-Device2026-02-11Class II

Tecfen Retractable Membrane Polisher, QTPR1267-23

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

Tecfen Retractable Membrane Polisher, QTPR1267-23

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1251-2026

Original summary

Tecfen Retractable Membrane Polisher, QTPR1267-23 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 817618024508 Box UDI 817618024508 Lot 2411013 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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