POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006. Used to gain access to the vascular system
FDA device recall Z-2254-2013 · posted 2013-09-18 · Terminated
Recall details
- Recalling firm
- Access Scientific Inc
- Reason for recall
- Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter because it is mislabeled.
- Action taken
- On 8/16/13, Access Scientific visited 2 consignees and initiated a field correction. This is the communication given to the two(2) accounts by our field personnel: "Access Scientific has inadvertently shipped mislabeled devices to your facility. The products affected were 5 Fr. POWERWANDs, Catalog # 92006, lot # I666473." The consignees were instructed to "Quarantine the devices until Access Scientific personnel arrived with the appropriate labeling and performed the corrective action of applying the correct labels to the devices and inserting the DFU into the boxes."
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 160 units
- Distribution
- Distributed in MI and TX.
- Date initiated
- 2013-08-16
- Date posted
- 2013-09-18
- Date terminated
- 2013-09-24
- Location
- San Diego, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER (K131300) | Access Scientific, LLC | 2013-06-07 |
| THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL (K121748) | Access Scientific, Inc. | 2012-07-27 |
| THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER (K111417) | Access Scientific, Inc. | 2011-07-15 |