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Terminated

Pneumothorax Kit

FDA Recall Z-1299-2018 · Posted None

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeKDD
Date Initiated2017-10-24
Date Terminated2020-04-17

Reason for Recall

Product packaging may not be completely sealed.

Firm Action

On October 24, 2017 and Urgent Medical Device Recall letter was issued to customers to review inventory and if there's any affected stock, to immediately discontinue use, quarantine and prepare to return to recalling firm. Questions or concerns can be directed to 1-855-419-8507 or 1-866-246-6990

Root Cause

Component design/selection

Distribution Pattern

Nationally

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K904021PNEUMOTHORAX KIT, MODIFICATIONArrow Intl., Inc. · 1990-10-09

Official Source

View FDA Recall →

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

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