Device product
INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01)
Z-0924-2022
Product summary
- Firm
- Abbott Vascular
- Event
- Event 89760
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6 lots
- Official record key
device-enforcement:Z-0924-2022
Official wording
Reason: Due to an increase in complaint trend for leaks and intermittent/loose connections.
Code information: Part Numbers: 1000183 Device Identifier-GTIN: 08717648013584 Lot Numbers: 60316775 60322179 60328352 60322176 60326322 60337153
Distribution pattern: 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
Derived failure modes
-
Unknown
Due to an increase in complaint trend for leaks and intermittent/loose connections.