The Recall Desk
ModerateFDA (Devices)·Z-1946-2014·Announced 2014-07-09

Origio Pasteur Pipets Recalled Due to Packaging Sterility Breach

Origio, Inc. is recalling Pasteur Pipets used in IVF laboratories because a breach in the nylon pouch sterile barrier was identified.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity level. The hazard is a packaging breach affecting sterility, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Origio, Inc. is recalling specific models of Pasteur Pipets used by embryologists in IVF laboratories. The affected models are PP-5.75-90, PP-9-90, PP-5.75-90PL, and PP-9-90PL. The recall involves lots with a labeled expiry date of May 2, 2015, or later.

The recall was initiated due to the identification of a packaging breach in the nylon pouch sterile barrier for the 3-pack configuration. This breach compromises the sterile barrier intended to protect the pipets.

A total of 32,760 boxes were distributed worldwide, including 4,093 in the US, 1,156 in Canada, and 27,511 in the EU and other regions. The products were distributed in numerous countries including Australia, China, Germany, Japan, and the United Kingdom. Users should stop using the affected pipets and contact the manufacturer for instructions.

The recalled product

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
Manufacturer
ORIGIO, Inc

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • 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

Distributed nationwide across the United States.