FDAFDA · Food and drugs·Recall number Z-1555-2020
Imager II 5F Angiographic Catheters, 5 units per package.
Published April 1, 2020 · Recall initiated: February 11, 2020
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
Potential for tip detachment of Imager II 5F Angiographic Catheters
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- Worldwide distribution. US nationwide, Australia, Belgium, Brazil, Canada, Switzerland, China, Colombia, Cyprus, Czech Republic, Germany, Spain, Finland, France, Great Britain, Greece, Croatia, Hungary, Indonesia, Israel, India, Italy, Jordan, Japan, South Korea, Lebanon, Lithuania, Mexico, Malaysia, Netherlands, Norway, Poland, Russia, Sweden, Slovakia, Turkey, Taiwan, and South Africa.
- Lot
- All lots of the following: 1 Material Number (UPN) Outer Package M001314041, Material Number (UPN) Inner Package M001314040 2 Material Number (UPN) Outer Package M001314051, Material Number (UPN) Inner Package M001314050 3 Material Number (UPN) Outer Package M001314061, Material Number (UPN) Inner Package M001314060 4 Material Number (UPN) Outer Package M001314071, Material Number (UPN) Inner Package M001314070 5 Material Number (UPN) Outer Package M001314081, Material Number (UPN) Inner Package M001314080 6 Material Number (UPN) Outer Package M001314091, Material Number (UPN) Inner Package M001314090 7 Material Number (UPN) Outer Package M001314101, Material Number (UPN) Inner Package M001314100 8 Material Number (UPN) Outer Package M001314111, Material Number (UPN) Inner Package M001314110 9 Material Number (UPN) Outer Package M001314121, Material Number (UPN) Inner Package M001314120 10 Material Number (UPN) Outer Package M001314131, Material Number (UPN) Inner Package M001314130 11 Material Number (UPN) Outer Package M001314141, Material Number (UPN) Inner Package M001314140 12 Material Number (UPN) Outer Package M001314151, Material Number (UPN) Inner Package M001314150 13 Material Number (UPN) Outer Package M001314161, Material Number (UPN) Inner Package M001314160 14 Material Number (UPN) Outer Package M001314171, Material Number (UPN) Inner Package M001314170 15 Material Number (UPN) Outer Package M001314181, Material Number (UPN) Inner Package M001314180 16 Material Number (UPN) Outer Package M001314191, Material Number (UPN) Inner Package M001314190 17 Material Number (UPN) Outer Package M001314211, Material Number (UPN) Inner Package M001314210 18 Material Number (UPN) Outer Package M001314221, Material Number (UPN) Inner Package M001314220 19 Material Number (UPN) Outer Package M001314231, Material Number (UPN) Inner Package M001314230 20 Material Number (UPN) Outer Package M001314241, Material Number (UPN) Inner Package M001314240 21 Material Number (UPN) Outer Package M001314251, Material Number (UPN) Inner Package M001314250 22 Material Number (UPN) Outer Package M001314261, Material Number (UPN) Inner Package M001314260 23 Material Number (UPN) Outer Package M001314271, Material Number (UPN) Inner Package M001314270 24 Material Number (UPN) Outer Package M001314301, Material Number (UPN) Inner Package M001314300 25 Material Number (UPN) Outer Package M001314311, Material Number (UPN) Inner Package M001314310 26 Material Number (UPN) Outer Package M001314321, Material Number (UPN) Inner Package M001314320 27 Material Number (UPN) Outer Package M001314331, Material Number (UPN) Inner Package M001314330 28 Material Number (UPN) Outer Package M001314341, Material Number (UPN) Inner Package M001314340 29 Material Number (UPN) Outer Package M001314351, Material Number (UPN) Inner Package M001314350 30 Material Number (UPN) Outer Package M001314361, Material Number (UPN) Inner Package M001314360 31 Material Number (UPN) Outer Package M001314371, Material Number (UPN) Inner Package M001314370 32 Material Number (UPN) Outer Package M001314391, Material Number (UPN) Inner Package M001314390 33 Material Number (UPN) Outer Package M001314401, Material Number (UPN) Inner Package M001314400 34 Material Number (UPN) Outer Package M001314411, Material Number (UPN) Inner Package M001314410 35 Material Number (UPN) Outer Package M001314421, Material Number (UPN) Inner Package M001314420 36 Material Number (UPN) Outer Package M001314431, Material Number (UPN) Inner Package M001314430 37 Material Number (UPN) Outer Package M001314441, Material Number (UPN) Inner Package M001314440 38 Material Number (UPN) Outer Package M001314451, Material Number (UPN) Inner Package M001314450 39 Material Number (UPN) Outer Package M001314461, Material Number (UPN) Inner Package M001314460 40 Material Number (UPN) Outer Package M001314471, Material Number (UPN) Inner Package M001314470 41 Material Number (U
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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