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Apparatus, Autotransfusion
FDA product code CAC · Class 2 · Anesthesiology
373
Registered devices
3,163
Adverse events
89
Recalls
195
510(k) clearances
Devices with this code
BRAT 2 — SORIN GROUP ITALIA SRLCrit-Line Cuvette — LIVANOVA USA, INC.XTRA — SORIN GROUP ITALIA SRLBOEHRINGER® AUTOVAC® 792600 with 1/8" (10Fr) PVC Drain & Trocar — BOEHRINGER LABORATORIES, LLCBLOOD COLLECTION RESERVOIR — SORIN GROUP ITALIA SRLXTRA — SORIN GROUP ITALIA SRLPLEUR-EVAC — TELEFLEX INCORPORATEDHAEMONETICS CELL SAVER 5/5+ SYSTEMS — HAEMONETICS CORPORATIONNA — MEDTRONIC, INC.NA — MEDTRONIC, INC.HAEMONETICS ORTHOPAT & CARDIOPAT SYSTEMS — HAEMONETICS CORPORATIONNA — MEDTRONIC, INC.XTRA — SORIN GROUP ITALIA SRLNA — MEDTRONIC, INC.XTRA — SORIN GROUP ITALIA SRLBRAT 2 — SORIN GROUP ITALIA SRLPROLONG* Continuous Nerve Block Set — Avanos Medical, Inc.HAEMONETICS CELL SAVER 5/5+ SYSTEM — HAEMONETICS CORPORATIONOCEAN — Atrium Medical CorporationHAEMONETICS CELL SAVER ELITE+ SYSTEM — HAEMONETICS CORPORATIONNA — MEDTRONIC, INC.Orthofuser — LIVANOVA USA, INC.ATF 40 Fast Start Kit — Fresenius Kabi AGNA — STRYKER CORPORATION
Recent 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 |
| 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 |
| 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 p |
| 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( |
| 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( |
| 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( |
| 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 |
| 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 |
| 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 |
| 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 |
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