MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat Exchanger is used as part of a cardioplegia sys
FDA device recall Z-1165-2014 · posted 2014-03-10 · Terminated
Recall details
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Reason for recall
- 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.
- Action taken
- 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 copy to Fieldactions@maquet.com or via fax at (973) 807-9290.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DTR
- Quantity affected
- 1,424 units
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Brazil, Germany and Turkey
- Date initiated
- 2014-01-31
- Date posted
- 2014-03-10
- Date terminated
- 2015-04-24
- Location
- Wayne, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30 (K090555) | Maquet Cardiopulmonary, AG | 2009-12-23 |