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CATSmart
Fresenius Kabi AG · Model 9005901 · UDI-DI 04086000860048
CAC
Prescription
3
510(k) clearances
3,163
Adverse events (82 deaths)
89
Recalls
55
Facilities
Description
The CATSmart (Continuous Autotransfusion System) by Fresenius is indicated for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-13 | Maquet Cardiovascular, LLC | Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectio |
| 2023-12-13 | Maquet Cardiovascular, LLC | Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectio |
| 2023-11-01 | Atrium Medical Corporation | A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. This nonconforming product was inadverte |
| 2023-09-18 | Atrium Medical Corporation | Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube |
| 2023-09-18 | Atrium Medical Corporation | Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube |
| 2023-09-18 | Atrium Medical Corporation | Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube |
| 2023-09-05 | Atrium Medical Corporation | Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation |
| 2019-10-21 | Haemonetics Corporation | Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl cor |
| 2019-10-21 | Haemonetics Corporation | Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl cor |
| 2019-10-21 | Haemonetics Corporation | Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl cor |
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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.