Z-1946-2014Class II

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

Name: Z-1946-2014 Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory. Model numbers: PP-5.75-90 PP-9-90...
Creator: ORIGIO, Inc
Published: 2014-06-20
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2014-06-20 / Terminated / root cause: packaging

FDA source

ORIGIO, Inc began a recall of 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 on 2014-06-20. FDA classified it as Class II and gives the reason as "Identification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1946-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-20
Posted: 2014-06-30
Terminated: 2015-07-20
Recalling firm: CooperSurgical, Inc.
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
Product code: MQK Labware, Assisted Reproduction
Reason for recall: Identification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Field Safety Corrective Action / Urgent Product Recall letter dated June, 2014.
Quantity in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1946-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1946-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-06-30

Product code MQK

K000915Class IIPasteur Pipet - Sterile 9, Pasteur Pipet - Sterile 5 3/4, Models 16-Pp-9, 16-Pp-5.75Humagen Fertility Diagnostics, Inc. / cleared 2000-05-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)