Recall Z-2254-2013— Access Scientific Inc
Class II · Terminated
Class II FDA medical device recall by Access Scientific Inc, initiated 2013-08-16, terminated 2013-09-24. It names 3 FDA 510(k) clearances: K131300, K121748, K111417. Product: 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.. Reason: Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter because it is mislabeled..
- Recalling firm
- Access Scientific Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-08-16
- Terminated
- 2013-09-24
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
3 on FDA's record- K131300 — THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
- K121748 — THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL
- K111417 — THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter because it is mislabeled.
Data sourced from openFDA. This site is unofficial and independent of the FDA.