Vortex Surgical Inc.: Vortex Surgical I2 Injection Kit, VS0500
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Vortex Surgical Inc.
- Product
- Vortex Surgical I2 Injection Kit, VS0500
- Reason / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2025-12-16
- Code info
- Pouch UDI 810123480920 Box UDI 810123481330 Lot 2411012
- Product quantity
- 14,789 (8651 US; 6138 OUS)
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Saint Charles
- State
- MO
- Country
- United States
- Event id
- 98255
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