Summary
The FDA issued a Class II for 20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01) by Abbott Vascular. Reason: Due to an increase in complaint trend for leaks and intermittent/loose connections..
Details
Source
Device Recall
External ID
Z-0921-2022
Action Date
2022-04-20
Status
Ongoing
Category
device
Product Description
20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)
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
Quantity Affected: 17 lots
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, 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
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-11
Company
Temecula, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Abbott Vascular has 11 FDA actions in our database, including 9 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abbott Vascular) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abbott Vascular have FDA actions?
Abbott Vascular has 11 FDA actions in our database, including 9 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0921-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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