FDA-Device2022-04-20Class II
20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)
Abbott Vascular
Hazard
Due to an increase in complaint trend for leaks and intermittent/loose connections.
Sold states
U.S Nationwide Distribution.: AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, TN, TX, VA, WA, and WI. O.U.S.: United Arab Emirates, France, Pakistan, Argentina, United Kingdom, Portugal, Australia, Greece, R¿union, Belgium, Guam, Romania, Brazil, Indonesia, Russian Federation, Bahamas, Israel, Saudi Arabia, Canada, India, Singapore, Switzerland, Italy, Slovakia, Chile, Jamaica, Thailand, China, Japan, Taiwan Republic of China, Colombia, Korea (South), Costa Rica, Luxembourg, Uruguay, Czech Republic, Mexico, Vietnam, Germany, Netherlands, South Africa, Dominican Republic, New Zealand, Spain, and Panama
Affected count
17 lots
Manufactured in
26531 Ynez Rd, N/A, Temecula, CA, United States
Products
20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0921-2022Don't want to check this manually?
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