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MICROTOOLS (Assisted Hatching Pipette)
Arsci Inc. · Model AH-3001 · UDI-DI 07540268000815
1
510(k) clearances
27
Adverse events
4
Recalls
25
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 Assisted Hatching Pipette is to be used by qualified personnel during In-Vitro Fertilization (IVF) or Assisted Reproduction Technology (ART) procedures in vitro, to puncture a hole in the zona pellucida to enable embryo assisted hatching using Tyrode’s acid solution. 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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Get your free API keyRead the docsData 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.