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IVF Pasteur Pipettes, glass, cotton plugged, length 9", in boxes of 90 consisting of 30 nylon tube packages of 3 pipette

FDA device recall Z-1220-2007 · posted 2007-09-18 · Terminated

Recall details

Recalling firm
Humagen Fertility Diagnostics, Inc.
Reason for recall
Pasteur pipettes for laboratory use were labeled as sterile but may have become contaminated.
Action taken
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
Status
Terminated
Product code
MQK
Quantity affected
160 boxes
Distribution
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.
Date initiated
2007-05-08
Date posted
2007-09-18
Date terminated
2007-10-29
Location
Charlottesville, VA

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Related 510(k) clearances

RecordFirmDate
PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75 (K000915)Humagen Fertility Diagnostics, Inc.2000-05-12