||September 18, 2013
||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.
|| Lot no. I666473
|Access Scientific Inc
3910 Sorrento Valley Blvd Ste 200
San Diego, California 92121-1419
|For Additional Information Contact
|Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter because it is mislabeled.
||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 in Commerce
||Distributed in MI and TX.