Skip to content
Recall Observatory FDA recall evidence

Device product

INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01)

Z-0924-2022

March 11, 2022

Class II

Product summary

Firm
Abbott Vascular
Event
Event 89760
Status
Ongoing
Classification
Class II
Quantity
6 lots
Official record key
device-enforcement:Z-0924-2022

Official wording

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

Code information: Part Numbers: 1000183 Device Identifier-GTIN: 08717648013584 Lot Numbers: 60316775 60322179 60328352 60322176 60326322 60337153

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.