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MICROTOOLS (Polar Body Biopsy Pipette)

Arsci Inc. · Model PB-30FP01 · UDI-DI 07540268000693

510(k) clearances

Adverse events

Recalls

Facilities

Description

A non-invasive, single-use micro-manipulation pipette used in the laboratory to inject, denude, mobilize, remove, aspirate, incise, manipulate or separate cells for the duration of In-Vitro Fertilization (IVF), Assisted Reproductive Technologies (ART), and Reproductive Medicine (RM) procedures. The Polar Body Biopsy Pipette is to be used by qualified personnel during In-Vitro Fertilization (IVF) or Assisted Reproduction Technology (ART) procedures in vitro, for the aspiration of polar bodies from oocytes for pre-implantation genetic diagnosis (PGD) on the genetic material in the biopsied cell(s). Intended for one-time use.

Recalls

Date	Firm	Reason
2019-03-27	CooperSurgical, Inc.	ICSI CUSTOM MICROPIPETTES the thirty-degree bend is absent
2008-03-02	Cook Vascular Inc.	mislabeled - 300 micron flexipets labeled as 130 micron and vice versa
2008-03-02	Cook Vascular Inc.	mislabeled - 300 micron flexipets labeled as 130 micron and vice versa
2007-12-17	Cook Vascular Inc.	mislabeled - 300 micron flexipets were labeled as 80 microns

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.