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Terminated

ARROW Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow electrophysiology catheters are intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording

FDA Recall Z-3197-2018 · Posted None

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeDRF
Date Initiated2018-07-30
Date Terminated2019-07-11
Product Quantity7 eaches

Reason for Recall

Products are labeled with an incorrect expiration date

Firm Action

Arrow International notified US consignee notification by letter on 30 JUL 2018 via FedEx 2-day mail. Account action: immediately discontinue use and quarantine any products with the product codes and lot numbers listed above, so that the affected products can be returned to Arrow. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected].

Root Cause

Error in labeling

Distribution Pattern

US in the state of PA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K945229ARROW MULTIPOLAR INTRACARDIAC ELECTRODE CATHETERSArrow Intl., Inc. · 1995-08-08

Official Source

View FDA Recall →

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

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