Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1220-2007

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

CooperSurgical, Inc. / initiated 2007-05-08 / Terminated / root cause: labeling and UDI

Humagen Fertility Diagnostics, Inc. began a recall of 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... on . The reason FDA records is "Pasteur pipettes for laboratory use were labeled as sterile but may have become contaminated". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-1220-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
CooperSurgical, Inc.
Product
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***
Product code
MQK Labware, Assisted Reproduction
Reason for recall
Pasteur pipettes for laboratory use were labeled as sterile but may have become contaminated.
Root cause tag
labeling and UDI
FDA root cause
Other
Action
The recalling firm notified consignees by phone and e-mail on 05/07/07. International consignees were advised to discard product for replacement.
Quantity in commerce
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.
Product codes and lots
160306022 EXP 1/22/2010 160306046 EXP 2/15/2010 160306065 EXP 3/6/2010