Reported Feb 6, 2013 · Terminated
Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55,…
Abbott Vascular
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Vascular · 26531 Ynez Rd · Temecula, CA · 92591-4630
Is this the product you have?
- Brand NameRX Accunet
- Embolic Protection System Common NameRX Accunet EPS
- Part Numbers101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. The RX Accunet EPS is indicated for use as a guide wire and embolic protection system
- Lot codes and dates
- Lot Number
108106110825611091361108056110817611090261109156111004611080361108166110901611090861109236110808611082661110076110817611092861108246110811611082261108306110819611093061
- Lot Number
- Amount recalled
- 1253 units (962 units in the US & Puerto Rico)
Where it was sold
- Nationwide
Why it was recalled
The recall was initiated because Abbot Vascular has discovered that the identified lots of the RX Accunet Embolic Protection System may exhibit difficult removal of the peel away sheath due to higher than normal wall thickness.
This product could cause temporary or reversible health problems — stop using it.
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