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Abbott Vascular Recall 89760

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

Abbott Vascular Recall 89760 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0924-2022
Event ID89760
Event DescriptionINDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01)
Product TypeDevices
DistributionU.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
Quantity6 lots
Recall ReasonDue to an increase in complaint trend for leaks and intermittent/loose connections.
Device Classification20220420
Device Code InfoPart Numbers: 1000183 Device Identifier-GTIN: 08717648013584 Lot Numbers: 60316775 60322179 60328352 60322176 60326322 60337153
Center Classification Date20220413
Recall Initiation Date20220311
Recalling FirmAbbott Vascular
Initial Notification Letter
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