20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01) 20/30 Priority Pack w/.115 RHV -
Summary
The FDA issued a Class II for 20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03 by Abbott Vascular. Reason: Due to an increase in complaint trend for leaks and intermittent/loose connections..
Details
Source
Device Recall
External ID
Z-0922-2022
Action Date
2022-04-20
Status
Ongoing
Category
device
Product Description
20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01) 20/30 Priority Pack w/.115 RHV - REF 1000186-115 WPL2122270-02 (2019-03-01)
Lot/Code Info: Part Numbers: 1000186 Device Identifier-GTIN: 08717648013614 Lot Number: 60317536 60320079 60325409 60317537 60320909 60326623 60317542 60320910 60329936 60318666 60320911 60334116; Part Numbers: 1000186-115 Device Identifier-GTIN: 08717648015274 Lot Number: 60311340 60318662 60329334 60311346 60318663 60334117 60317538 60318664 60334737 60318661 60318665
Quantity Affected: 23 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-0922-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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