Abbott Vascular Recall 89760
Description: 20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)
Abbott Vascular Recall 89760 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0921-2022 |
Event ID | 89760 |
Event Description | 20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01) |
Product Type | Devices |
Distribution | 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 |
Quantity | 17 lots |
Recall Reason | Due to an increase in complaint trend for leaks and intermittent/loose connections. |
Device Classification | 20220420 |
Device Code Info | 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 |
Center Classification Date | 20220413 |
Recall Initiation Date | 20220311 |
Recalling Firm | Abbott Vascular |
Initial Notification | Letter |
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