Cook Flexipet
Flexipet Manipulation Pipette
2manufacturers in China registered for this device type
12catalogue numbers in this listing
3recalls on this code
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Huada Biotechnology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 9 |
| Guangzhou Pinzhi Medical Device Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 5 |
Record
| Listed by | Cook Vandergrift Inc., United States |
|---|---|
| FDA product code | MQH |
| Device type | Microtools, Assisted Reproduction (Pipettes) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6130 |
| Establishment | Complaint-file establishment, Manufacturer |
| Record published | 2016-09-24 |
| Record revised | 2025-12-04 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place. |
| Packaging | Pack of 5, pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| G46017 | In distribution | ||
| G46021 | 10 | In distribution | |
| G46019 | In distribution | ||
| G46020 | 10 | In distribution | |
| G26712 | 10 | In distribution | |
| G26057 | 10 | In distribution | |
| G26181 | In distribution | ||
| G26711 | 10 | In distribution | |
| G26713 | 10 | In distribution | |
| G46018 | In distribution | ||
| G18878 | In distribution | ||
| G26718 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Wallace | ICU Medical, Inc | 452 |
| Microtools, Assisted Reproduction (Pipettes) | Origio, Inc. | 264 |
| RI Pipettes | Research Instruments Ltd | 201 |
| Icsi Pipette | Vitrolife Inc. | 75 |
| Biopsy Pipette | Vitrolife Inc. | 38 |
| EZ-Tip | Coopersurgical, Inc. | 29 |
| EZ-Tip | Research Instruments Ltd | 29 |
| Stripper | Origio, Inc. | 27 |
| Holding Pipette | Vitrolife Inc. | 25 |
| Cook | Cook Vandergrift Inc. | 15 |
| Hatching Pipette | Vitrolife Inc. | 15 |
| Microtools (Biopsy Pipette) | Arsci Inc. | 12 |
Showing 12 of 38. All products under Microtools, Assisted Reproduction (Pipettes)
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2008-03-02 | Not classified | Employee error | mislabeled – 300 micron flexipets labeled as 130 micron and vice versa | 100 boxes | 2008-09-18 |
| 2008-03-02 | Not classified | Employee error | mislabeled – 300 micron flexipets labeled as 130 micron and vice versa | 120 boxes | 2008-09-18 |
| 2007-12-17 | Not classified | Employee error | mislabeled – 300 micron flexipets were labeled as 80 microns | 35 vials | 2008-09-16 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.