20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)
Check against the official notice below — it lists the full affected range.
Abbott Vascular is recalling the 20/30 Indeflator (Reference 1000184) across 17 lots due to an increase in complaints about leaks and intermittent or loose connections in the device. The affected devices were distributed nationwide throughout the United States as well as internationally to the United Arab Emirates, France, Pakistan, Argentina, United Kingdom, Portugal, Australia, Greece, Réunion, Belgium, Guam, Romania, Brazil, Indonesia, Russian Federation, Bahamas, and Israel.
The recall involves specific lot numbers ranging from 60309678 through 60334492. The source document does not specify any remedy, replacement procedure, or actions that affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Due to an increase in complaint trend for leaks and intermittent/loose connections.
Reason for recall: Due to an increase in complaint trend for leaks and intermittent/loose connections. 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, Quantity: 17 lots Lot/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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.