basixTOUCH Inflation Device, REF: IN8140/A

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): IN8140/A/00884450627105/H2925218(4/22/2027), H2929411(4/29/2027), H2938003(4/30/2027), H2972592(4/30/2027), H2982505(12/31/2026).

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.