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FDA (Device enforcement)Recalled 2022-03-11class ii

Abbott Vascular: 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)

Is my product affected?

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)

  • UPC 08717648013614
  • UPC 08717648015274

Check against the official notice below — it lists the full affected range.

What happened

Abbott Vascular is recalling two models of its 20/30 Priority Pack Accessory Kit—the model with .096 RHV (Part Number 1000186) and the model with .115 RHV (Part Number 1000186-115)—due to an increase in complaints about leaks and intermittent or loose connections. The recall affects 23 lots distributed nationwide across all U.S. states, Washington D.C., and Puerto Rico, as well as internationally to the United Arab Emirates, France, Pakistan, Argentina, United Kingdom, Portugal, Australia, Greece, Réunion, Belgium, Guam, Romania, Brazil, Indonesia, Russian Federation, Bahamas, and Israel.

The specific lot numbers affected are listed in the recall record by part number. The source document does not specify a remedy or corrective action for consumers who have this product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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, Quantity: 23 lots 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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