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Apparatus, Autotransfusion
FDA product code CAC · Class 2 · Anesthesiology
377
Registered devices
3,178
Adverse events
89
Recalls
196
510(k) clearances
Devices with this code
NA — MEDTRONIC, INC.CBCII ConstaVac — STRYKER CORPORATIONC.A.T.S — Fresenius Kabi AGXTRA — LivaNova Deutschland GmbHautoLog® — MEDTRONIC, INC.PLEUR-EVAC — TELEFLEX INCORPORATEDH.A.S.® — ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.SURETRANS — Davol Inc.HAEMONETICS CELL SAVER ELITE SYSTEM — HAEMONETICS CORPORATIONPROLONG* Continuous Nerve Block Set — Avanos Medical, Inc.NA — MEDTRONIC, INC.AUTOTRANSFUSION ACCESSORIES — SORIN GROUP ITALIA SRLEXPRESS — Atrium Medical CorporationNA — MEDTRONIC, INC.BRAT Accessory — LIVANOVA USA, INC.NA — STRYKER CORPORATIONHAEMONETICS ORTHOPAT ADVANCE SYSTEM — HAEMONETICS CORPORATIONNA — STRYKER CORPORATIONXTRA — SORIN GROUP ITALIA SRLOrthofuser — LIVANOVA USA, INC.NA — MEDTRONIC, INC.PREASSEMBLED SURGICAL WASH SET — SORIN GROUP ITALIA SRLH.A.S.® — ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.HAEMONETICS CELL SAVER SYSTEM — HAEMONETICS 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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