The GISH Vision Hollow Fiber Oxygenator with GBS coating (a non-leaching heparin coating) is a sterile, non-pyrogenic, s
FDA device recall Z-0519-06 · posted 2006-02-14 · Terminated
Recall details
- Recalling firm
- Gish Biomedical Inc
- Reason for recall
- Gish received four reports of potential leakage. All reports were associated with GBS coating. There was no patient injury reported.
- Action taken
- The firm faxed all initial consignees a letter notifying them of the recall and the affected lots involved. 11/14/2005 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. Customer Service will, at the same time, issue a SORMA for the return of coated oxygenators from the consignee. Sequester the coated oxygenator for return to Gish Biomedical. If the consignees prefer, they can provide a contact name and the number of packages to be picked up and the firm will issue a Federal Express call tag for pick-up at the earliest scheduled time.
- Root cause
- Other
- Status
- Terminated
- Product code
- DTZ
- Quantity affected
- 2,306
- Distribution
- Nationwide (CA, FL, IL, IN, MA, MI, MS, NH, NJ, NY, OH, PA, WI, VA), Canada, and Mexico.
- Date initiated
- 2005-11-28
- Date posted
- 2006-02-14
- 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 HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING (K023381) | Gish Biomedical, Inc. | 2003-03-31 |