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Terminated

BD EdgeAhead Stiletto/MVR Knife 1.1mm (19g) REF 585240

FDA Recall Z-1344-04 · Posted 2004-08-14

Recalling FirmBD Opthalmic Systems
Recall StatusTerminated
Product CodeHNN
Date Initiated2004-09-16
Date Terminated2005-02-17
Product Quantity6945 units

Reason for Recall

Blade may become detached from the handle

Firm Action

BD Medical initiated recall by telephone the week of 7/19/04 to direct accounts advising of the recall action, requesting return and providing replacement product.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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