PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: April 20, 2022 Initiated: March 11, 2022 #Z-0924-2022

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.

Details

Recalling Firm
Abbott Vascular
Units Affected
6 lots
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
Location
Temecula, CA

Frequently Asked Questions

What product was recalled?
INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01). Recalled by Abbott Vascular. Units affected: 6 lots.
Why was this product recalled?
Due to an increase in complaint trend for leaks and intermittent/loose connections.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 20, 2022. Severity: Moderate. Recall number: Z-0924-2022.