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Terminated

Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85400

FDA Recall Z-2531-2017 · Posted None

Recalling FirmCreganna Medical Devices
Recall StatusTerminated
Product CodeDYB
Date Initiated2017-05-22
Date Terminated2018-05-29
Product Quantity100 uniits

Reason for Recall

Lack of sterility assurance.

Firm Action

The firm notified their sole consignee by email on 05/22/2017 requesting all lots of product be recalled.

Root Cause

Packaging

Distribution Pattern

Distributed in MA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K131079CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRICCreganna Medical Devices · 2013-08-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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