Cook Urological, Inc. Koyle Diaper Stent 6.0 Fr, Sterile, GPN G17667, REF KDSCF-060050.
FDA device recall Z-0966-2011 · posted 2011-01-25 · Terminated
Recall details
- Recalling firm
- Vance Products Inc. dba Cook Urological Inc. & Cook OB/GYN
- Reason for recall
- The firm received a complaint that 15 units of the Koyle Diaper Stent were received in packages that had not been sealed. Each stent should be sealed in a poly-Tyvek pouch.
- Action taken
- The firm sent an URGENT RECALL NOTICE to one consignee on 12/13/2010 (the other consignee returned all their product as a complaint). The letter informed the consignee of the recall and asked the customer to return the recalled product.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- KOD
- Quantity affected
- 25 stents
- Distribution
- CA, CT
- Date initiated
- 2010-12-13
- Date posted
- 2011-01-25
- Date terminated
- 2011-01-31
- Location
- Spencer, IN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VPI-FAIR URETHRAL STENT (K820313) | Vance Products, Inc. | 1982-03-01 |