The GISH Vision Blood Cardioplegia System with GBS coating (a non-leaching heparin coating) (product desgination VBCXGBS
FDA device recall Z-0575-06 · posted 2006-03-01 · Terminated
Recall details
- Recalling firm
- Gish Biomedical Inc
- Reason for recall
- The coated Gish Vision Blood Cardioplegia Systems are associated with an increased incidence of heat exchanger leaks.
- Action taken
- The firm faxed all initial consignees a letter notifying them of the recall and the affected lots involved. The consignee was instructed to immediately inspect their inventory, and if any units of the affected product remain, the consignee is to contact Gish Biomedical Customer Service at 866-221-9911. The consignee is to provide catalogue number, lot number and quantity and state the reason for replacement is the recall letter. Gish Customer Service, in conjunction with the sales representative and customer pack office, will work with the consignee in an effort to resolve inventory and configuration issues.
- Root cause
- Other
- Status
- Terminated
- Product code
- DTZ
- Quantity affected
- 1, 216
- Distribution
- CA, FL, IN, MA, MI, NJ, NY
- Date initiated
- 2005-11-28
- Date posted
- 2006-03-01
- Date terminated
- 2007-06-21
- Location
- Rancho Santa Margarita, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING (K040355) | Gish Biomedical, Inc. | 2004-03-15 |