FDAClass IIJuly 9, 2014

Name: Pasteur Pipets recall: Sterility Concern

Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory. Model numbers: PP-5.75-90 PP-9-90 PP-5.75-90PL PP-9-90PL

Why was Name: Pasteur Pipets recalled?

Identification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

CODE: Model #s: PP-5.75-90, PP-9-90, PP-5.75-90PL, PP-9-90PL. Lots with labeled expiry date of May 2, 2015, or later.

Product
Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory. Model numbers: PP-5.75-90 PP-9-90 PP-5.75-90PL PP-9-90PL
Recalling firm
ORIGIO, Inc
Quantity
Total number of Boxes Distributed 32,760. US 4,093 / Canada 1,156 / EU & Other 27,511
Distribution
Worldwide Distribution: US Nationwide, Canada, Australia, Barbados, Chile, China, Colombia, Denmark, Ecuador, France, Germany, Great Britain, Greece, India, Italy, Japan, Jordan, Malaysia, Netherlands, Peru, Russia, Singapore, South Africa, Spain, Taiwan, Turkey, and United Arab Emirates.
Recall date
July 9, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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