Recall Z-2254-2013 ยท DYB Introducer, Catheter
Access Scientific Inc
POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006. Used to gain access to the vascular system to sample blood and administer fluids intravenously.
| Date | Sep 18, 2013 (initiated Aug 16, 2013) |
| Status | Terminated |
| Reason | Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter because it is mislabeled. |
| Root cause | Labeling Change Control |
| Action | 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." |
| Quantity | 160 units |
| Distribution | Distributed in MI and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111417 | THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER Access Scientific, Inc., Jul 15, 2011 |
| K121748 | THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL Access Scientific, Inc., Jul 27, 2012 |
| K131300 | THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER Access Scientific, LLC, Jun 7, 2013 |