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BRAT 2
SORIN GROUP ITALIA SRL · Model SUCTION ASSEMBLY (Twist Lock) · UDI-DI 08033178106146
CAC
Prescription
1
510(k) clearances
3,163
Adverse events (82 deaths)
89
Recalls
55
Facilities
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.