Arrow Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 Fr. Catheters; Catalo
FDA device recall Z-2274-2010 · posted 2010-08-25 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- Sterility not assured. The stopcock handle position was inadvertently changed from an open to a closed position, which prevents sterilization of the closed portion of the device. Sterility of the affected product cannot be guaranteed.
- Action taken
- June 7, 2010 Notification letter to customer instructed them to return the product to Arrow. Arrow will destroy the returned product.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- KGZ
- Quantity affected
- 3000 kits
- Distribution
- All affected product was distributed to one foreign consignee: Arrow Japan Ltd.
- Date initiated
- 2010-06-07
- Date posted
- 2010-08-25
- Date terminated
- 2012-09-29
- Location
- Reading, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADAPTER, CATHETER SHEATH (K781846) | Arrow Intl., Inc. | 1978-12-12 |