Merit Medical Systems, Inc.: basixSKY Inflation Device, REF: SKY1802

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: 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. Quantity: 70 Lot/code info: REF/UDI-DI/Lot(Expiration): SKY1802/00884450822500/H2925228(11/30/2026), H2934728(11/30/2026).

UPC codes

00884450822500

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.