FDAFDA · Food and drugs·Recall number Z-0925-2022
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)
Published April 20, 2022 · Recall initiated: March 11, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to an increase in complaint trend for leaks and intermittent/loose connections.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott Vascular
- Distributor
- 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
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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