Boston Scientific Imager II Angiographic Catheter Recall for Missing Seal
Boston Scientific is recalling Imager II Angiographic Catheters because some units are missing the bottom pouch seal. The defect is obvious to the user.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a packaging defect (missing seal) that is explicitly described as obvious to the user, and no injuries or illnesses are reported in the source text.
Plain-English summary
Boston Scientific Corporation is recalling 39 boxes (195 units) of Imager II Angiographic Catheters, lot 00112758, with a use-by date of May 11, 2018. The affected product is a medical device used to deliver contrast media to selected sites in the vascular system.
The recall was initiated after a field report indicated that some units within this lot were missing the bottom pouch seal. The source text notes that the compromised seal is completely missing and is obvious to the user.
The affected units were distributed in California, Florida, Kentucky, Missouri, New Mexico, Oklahoma, Oregon, Pennsylvania, and Texas. Users should check their inventory for this specific lot and use-by date. If the bottom pouch seal is missing, the device should not be used.
The recalled product
- Product
- 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)
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Catheter
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 00112758
- Use by 2018-05-11
Distribution
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