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Terminated

IVF Pasteur Pipettes, glass, cotton plugged, length 9", in boxes of 90 consisting of 30 nylon tube packages of 3 pipettes each. Item # PP-9-90PL. Boxes are labeled in part ***Humagen Fertility Diagnostics, Inc. 2400 Hunter's Way Charlottesville, VA 22911***

FDA Recall Z-1220-2007 · Posted 2007-09-18

Recalling FirmHumagen Fertility Diagnostics, Inc.
Recall StatusTerminated
Product CodeMQK
Date Initiated2007-05-08
Date Terminated2007-10-29
Product Quantity160 boxes

Reason for Recall

Pasteur pipettes for laboratory use were labeled as sterile but may have become contaminated.

Firm Action

The recalling firm notified consignees by phone and e-mail on 05/07/07. International consignees were advised to discard product for replacement.

Root Cause

Other

Distribution Pattern

The recalled product was distributed to 2 direct accounts in IL and to 6 international distributors in United Kingdom, Greece, Australia, United Arab Emirates, the Netherlands, and Israel.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K000915PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75Humagen Fertility Diagnostics, Inc. · 2000-05-12

Official Source

View FDA Recall →

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

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