Z-0924-2022 Class II Ongoing

Recalled by Abbott Vascular — Temecula, CA

Recall Details

Product Type
Devices
Report Date
April 20, 2022
Initiation Date
March 11, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6 lots

Product Description

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

Reason for Recall

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

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

Code Information

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