FDAClass IIApril 20, 2022

Indeflator Plus 30 recall

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

Why was Indeflator Plus 30 recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01)
Recalling firm
Abbott Vascular
Quantity
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
Recall date
April 20, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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