Z-2645-2017 Class II Terminated
FDA device recall Z-2645-2017 was initiated by Boston Scientific Corporation on Dec 15, 2016 and is designated Class II. 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. The recall status is terminated (terminated Apr 10, 2018). Affected quantity: 39 boxes of 5 (195 units).
Recall Details
- Product Type
- Devices
- Report Date
- Jul 12, 2017
- Initiation Date
- Dec 15, 2016
- Termination Date
- Apr 10, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 39 boxes of 5 (195 units)
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.
Distribution Pattern
CA, FL, KY, MO, NM, OK, OR, PA, and TX.
Code Information
Lot: 00112758, Use by 2018-05-11
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2645-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026