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Terminated

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

FDA Recall Z-1946-2014 · Posted 2014-06-30

Recalling FirmORIGIO, Inc
Recall StatusTerminated
Product CodeMQK
Date Initiated2014-06-20
Date Terminated2015-07-20
Product QuantityTotal number of Boxes Distributed 32,760. US 4,093 / Canada 1,156 / EU & Other 27,511

Reason for Recall

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

Firm Action

Field Safety Corrective Action / Urgent Product Recall letter dated June, 2014.

Root Cause

Package design/selection

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K000915PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75Humagen Fertility Diagnostics, Inc. · 2000-05-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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