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)
Reported: July 12, 2017 Initiated: December 15, 2016 #Z-2645-2017
Product Description
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)
Reason for Recall
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.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 39 boxes of 5 (195 units)
- Distribution
- CA, FL, KY, MO, NM, OK, OR, PA, and TX.
- Location
- Maple Grove, MN
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by Boston Scientific Corporation. Units affected: 39 boxes of 5 (195 units).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 12, 2017. Severity: Moderate. Recall number: Z-2645-2017.
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