Haemonetics cardioPAT -Cardiovascular Perioperative Autotransfusion System Model 2050 US Models Out-Side the US: 02050-U
FDA device recall Z-2956-2011 · posted 2011-08-05 · Terminated
Recall details
- Recalling firm
- Haemonetics Corporation
- Reason for recall
- Updated Operations Manual for the deployment of the spill collection system and cleaning
- Action taken
- Haemonetics sent a "FIELD NOTIFICATION: UPDATE OF CardioPAT OPERATIONS MANUAL FOR DEPLOYMENT OF SPILL COLLECTION BAG AND CLEANING" letter dated July 27, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter requests that customers complete an enclosed Customer Confirmation sheet indicating that the affected devices are in their possession and to return the sheet via fax to Haemonetics at 781-987-9252. Additionally, instructions for deployment of the spill collection drainage system, revised Operations Manual and Quick Reference Guide Addendum are enclosed with the letter. Contact Haemonetics at 1-800-537-2802 for questions regarding this notice..
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- CAC
- Quantity affected
- 316 units
- Distribution
- Worldwide Distribution--USA (nationwide) and the countries of Canada, France, Germany, Great Britain, Italy, Japan, Spain, and The Netherlands.
- Date initiated
- 2011-07-27
- Date posted
- 2011-08-05
- Date terminated
- 2014-06-09
- Location
- Braintree, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT) (K053000) | Haemonetics Corp. | 2005-11-21 |