FDAClass IIApril 20, 2022

20/30 Priority Pack Accessory Kit/.096 RHV recall

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…

Why was 20/30 Priority Pack Accessory Kit/.096 RHV 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: 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

Product
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…
Recalling firm
Abbott Vascular
Quantity
23 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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