Recall Z-1946-2014— ORIGIO, Inc

Name: FDA recall Z-1946-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-20

Class II · Terminated

Class II FDA medical device recall by ORIGIO, Inc, initiated 2014-06-20, terminated 2015-07-20. It names one FDA 510(k) clearance: K000915. 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. Reason: Identification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration.

Recalling firm: ORIGIO, Inc
Classification: Class II
Status: Terminated
Initiated: 2014-06-20
Terminated: 2015-07-20
Firm location: Charlottesville, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K000915 — PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75Humagen Fertility Diagnostics, Inc.·cleared 2000-05-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.