FDA-Device2026-02-11Class IIPACKAGING DEFECT
Vortex Surgical I2 Injection Kit recalled for compromised sterile barrier
Nationwide distributionMedical devices
What this means
Vortex Surgical I2 Injection Kits (model VS0500) in certain lots may have small voids or gaps in the seal of their sterile Tyvek pouches. This damage can allow bacteria to contaminate the sterile contents, potentially causing infection if the kit is used.
- Check if you have Vortex Surgical I2 Injection Kit lot 2411012 with pouch UDI 810123480920 or box UDI 810123481330
- Do not use affected kits
- Contact your healthcare facility or Vortex Surgical for instructions on returning or replacing the product
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
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 I2 Injection Kit, VS0500
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1252-2026Want us to check the next one for you?
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