ORIGIO, Inc: Medical Device Recall in 2014 - (Recall #: Z-1946-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: June 20, 2014

Date Posted: July 9, 2014

Recall Number: Z-1946-2014

Event ID: 68592

Reason for Recall:

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

Status: Terminated

Product Quantity: Total number of Boxes Distributed 32,760. US 4,093 / Canada 1,156 / EU & Other 27,511

Code Information:

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.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated