Product Wiki · Recalls · Health Canada — Medical Devices

Imager II Catheters (2016-12-21) — recall 56417

Health Canada — Medical Devices · Canada · 2017-01-18 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
56417
Date of alert
2017-01-18
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Boston Scientific has determined some units within a single lot were missing the bottom pouch seal. This is caused by an alternate label reprint process which resulted in the units missing a step in the packaging process. Although Boston Scientific has confirmed that only one batch (note: Canada did not receive the one non-conforming batch) was missing a bottom seal, as a precautionary measure, we are notifying all customers of this issue that received batches processed through this alternate label reprint process.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/imager-ii-catheters-2016-12-21

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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