Stryker Infravision Esophageal Kit, Model Numbers 220180548, 220180540, 220180560, manufactured by Stryker Endoscopy San
FDA device recall Z-0830-2011 · posted 2010-12-28 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- Reason for recall
- The silicone sheath component of the product detaches from the catheter during removal of the e-kit from the body.
- Action taken
- Stryker issued Urgent Product Recall letters dated August 20, 2009 to all its direct consignees, informing them of the affected products and providing instructions on the recall. Customers were requested to return the affected product to Styrker.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FAT
- Quantity affected
- 2985 units
- Distribution
- Worldwide Distribution: USA in the states of: Alabama, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachuset
- Date initiated
- 2009-08-20
- Date posted
- 2010-12-28
- Date terminated
- 2011-01-03
- Location
- San Jose, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRYKER INFRAVISION ESOPHAGEAL KIT (K983220) | Stryker Endoscopy | 1999-06-04 |