Device product
StabiliT TOUCH Syringe, REF: IN8VCF/B
Z-0073-2025
Product summary
- Event
- Event 95343
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 202
- Official record key
device-enforcement:Z-0073-2025
Official wording
Reason: Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
Code information: REF/UDI-DI/Lot(Expiration): IN8VCF/B/00884450662144/H2918440(5/31/2027), H2938015(7/26/2027).
Distribution pattern: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, Japan.
Derived failure modes
-
Unknown
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.