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Recall Observatory FDA recall evidence

Device product

20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)

Z-0921-2022

March 11, 2022

Class II

Product summary

Firm
Abbott Vascular
Event
Event 89760
Status
Ongoing
Classification
Class II
Quantity
17 lots
Official record key
device-enforcement:Z-0921-2022

Official wording

Reason: Due to an increase in complaint trend for leaks and intermittent/loose connections.

Code information: Part Numbers: 1000184 Device Identifier-GTIN: 08717648013591 Lot Numbers: 60309678 60320071 60337162 60311336 60320899 60337166 60311338 60331726 60311337 60311339 60331727 60317539 60315914 60334491 60318209 60317535 60334492

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to an increase in complaint trend for leaks and intermittent/loose connections.