Recall Z-1165-2014 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
Maquet Cardiovascular Us Sales, Llc
MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat Exchanger is used as part of a cardioplegia system to set and maintain temperature for given flow rates and within the given temperature range of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The product is designed for single use only, for an application period of no longer tha
| Date | Mar 10, 2014 (initiated Jan 31, 2014) |
| Status | Terminated |
| Reason | The MAQUET post-marketing vigilance program has identified a discrepancy that the desired cardioplegia temperature may not be obtained when the PLEGIOX Cardioplegia Heat Exchanger (PLEGIOX) is used in conjunction with a heater/cooler unit. |
| Root cause | Device Design |
| Action | Maquet Inc.sent an" Field Safety Notice" dated January 31, 2014, to all affected customers via Fed Ex. The letter identified the product the problem and the action needed to be taken by the customer. Any questions or additional information, can be obtained from the MAQUET representative, or MAQUET Customer Service at 1-888-627-8383 (press option 2, followed by option 3), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST. Please complete and return the enclosed confirmation form, acknowledging your receipt and understanding of this communication, by emailing a scanned co |
| Quantity | 1,424 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Brazil, Germany and Turkey |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090555 | PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30 Maquet Cardiopulmonary, AG, Dec 23, 2009 |