FDAFDA · Food and drugs·Recall number Z-3055-2020
Pacific Xtreme (PTCA Balloon Dilation Catheter)
Published October 7, 2020 · Recall initiated: August 26, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling discrepancy for the Rated Burst Pressure (RBP) value.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ev3 Inc.
- Distributor
- Domestic Distribution: AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL,IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX,VA, WA, WI and WV. International Distribution: Canada and Puerto Rico.
- Lot
- Model: PCU060150090 Lot Numbers: 217978890, 218622060. Model: PCU060150130 Lot Numbers: 217466573, 217603335, 217790972, 217860448, 217876552, 217892598, 217951979, 218153799, 218217163, 218424513, 218482262, 218557813, 218639138, 218712737, 218732096, 218745770, 218815063, 218902560, 218998027, 219036544, 219105117, 219113539, 219236001, 219245043, 219369215, 219544768, 219690958. Model Number: PCU060200090 Lot Number:217978889 Model Number: PCU060200130 Lot Numbers: 217371273, 217466571, 217617124, 217799993, 217876554, 217914347, 217951978,218037674, 218153802, 218247209, 218321788, 218502816, 218569122, 218655092, 218712742, 218723547, 218732101, 218745773, 218815056, 218846687, 218902556, 218994904, 219018137, 219097771, 219105115, 219113534, 219235998, 219245040, 219333058, 219369216, 219377669, 219444491, 219582240, 219598484, 219690961. Model Number: PCU060250090 Lot Number: 217603333 Model Number: PCU060250130 Lot Numbers: 217371272, 217451265, 217741799, 217799997, 217867045, 217876555, 218153797, 218217158, 218239743, 218247216, 218424511, 218471575, 218502814, 218569123, 218732098, 218745771, 218815057, 218892319, 218994905, 219018141, 219036626, 219113533, 219235999, 219245041, 219290848, 219358711, 219444490, 219666731. Model Number: PCU060300090 Lot Numbers: 217790974, 218179770. Model Number: PCU060300130 Lot Numbers: 217466572, 217558443, 217693877, 217728143, 217741797, 217867826, 217892596, 217914351, 218033558, 218079623, 218170536, 218217164, 218247211, 218321790, 218454476, 218569121, 218655090, 218712741, 218723546, 218752665, 218815061, 218892317, 219018140, 219097767, 219105116, 219217703, 219235996, 219290780, 219369212, 219544769, 219582241, 219598482, 219666726. Expiration dates are from 03/22/2022 to 04/21/2023
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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