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Abbott Vascular Recall 89760

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

Abbott Vascular Recall 89760 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0921-2022
Event ID89760
Event Description20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (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
Quantity17 lots
Recall ReasonDue to an increase in complaint trend for leaks and intermittent/loose connections.
Device Classification20220420
Device Code InfoPart 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
Center Classification Date20220413
Recall Initiation Date20220311
Recalling FirmAbbott Vascular
Initial Notification Letter
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