Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV - REF 100018
Summary
The FDA issued a Class II for Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus by Abbott Vascular. Reason: Due to an increase in complaint trend for leaks and intermittent/loose connections..
Details
Source
Device Recall
External ID
Z-0925-2022
Action Date
2022-04-20
Status
Ongoing
Category
device
Product Description
Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV - REF 1000185-115 WPL2122279-01 (2019-03-01)
Lot/Code Info: Part Numbers: 1000185 Device Identifier-GTIN: 8717648013607 Lot Numbers: 60317532 60323314 60329935 60323313 60326601 Part Numbers: 1000185-115 Device Identifier-GTIN: 08717648015267 Lot Numbers: 60316763 60323315
Quantity Affected: 7 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-0925-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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