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Terminated

5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530.

FDA Recall Z-1230-2007 · Posted 2007-09-20

Recalling FirmMentor Texas, Inc
Recall StatusTerminated
Product CodeMUU
Date Initiated2007-07-27
Date Terminated2008-04-04
Product Quantity4 units

Reason for Recall

Mis-identified and mis-labeled surgical probes were distributed. 5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530 was shipped, instead of LySonix 5mm x 30cm Hollow Bullet Tip Ultrasonic Probe, Catalog Number 5610-530.

Firm Action

Firm notified consignees by letter on July 27, 2007.

Root Cause

Other

Distribution Pattern

Nationwide, including VA, IN, CA, and IL.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041058MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMSMisonix, Inc. · 2004-05-17

Official Source

View FDA Recall →

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

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