FDAFDA · Food and drugs·Recall number Z-2645-2017
Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inner package UPN)
Published July 12, 2017 · Recall initiated: December 15, 2016
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
A field report indicated some units within this lot were missing the bottom pouch seal. The compromised seal is completely missing and is obvious to the user.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- CA, FL, KY, MO, NM, OK, OR, PA, and TX.
- Lot
- Lot: 00112758, Use by 2018-05-11
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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