Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN)
Reported: April 19, 2017 Initiated: December 13, 2016 #Z-1781-2017
Product Description
Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN)
Reason for Recall
One lot of Imager II Angiographic Catheters is being recalled due to packaging mislabeling. The product may be labeled as Imager II Contra 2 curve catheters, when in fact the package contains Contra curve catheters.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 26 boxes of 5 (130 singles)
- Distribution
- AZ, FL, MO, NJ, NY, OH, PA, and TX.
- Location
- Maple Grove, MN
Frequently Asked Questions
What product was recalled? ▼
Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN). Recalled by Boston Scientific Corporation. Units affected: 26 boxes of 5 (130 singles).
Why was this product recalled? ▼
One lot of Imager II Angiographic Catheters is being recalled due to packaging mislabeling. The product may be labeled as Imager II Contra 2 curve catheters, when in fact the package contains Contra curve catheters.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 19, 2017. Severity: Moderate. Recall number: Z-1781-2017.
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