Pinnacle Destination Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to faci
FDA device recall Z-1611-2013 · posted 2013-06-27 · Terminated
Recall details
- Recalling firm
- Terumo Medical Corporation
- Reason for recall
- Medical devices were incorrectly labeled with extended expiration dates.
- Action taken
- The recalling firm notified consignees by letter on 5/30/2013. The letter was flagged as an urgent product bulletin addressed to risk managers. The notification advised customers to immediately discontinue use and quarantine any available stock for subsequent instructions to be provided for pick-up and replacement.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 20 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2013-05-30
- Date posted
- 2013-06-27
- Date terminated
- 2013-10-30
- Location
- Elkton, MD
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH (K091329) | Terumo Medical Corp. | 2009-05-29 |