Bard PowerLine 6 Fr. Dual-Lumen Polyurethane Catheter with SureCuff Ingrowth Cuff, REF 0700610, Sterile, Contents...1 Ea
FDA device recall Z-2783-2011 · posted 2011-07-11 · Terminated
Recall details
- Recalling firm
- Bard Access Systems
- Reason for recall
- Kit label indicates the wrong dimension for an enclosed introducer.
- Action taken
- Bard Access Systems, Inc. notified customers by letter dated June 16, 2011. The letter notified customers of the mislabeling issue and offered a replacement product if desired. For additional information contact Bard Access Systems at 1-800-443-3393.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- LJS
- Quantity affected
- 6,485 units
- Distribution
- Worldwide distribution - USA (nationwide) including the states of: HI, KY, TX, VT and the country of Canada.
- Date initiated
- 2011-06-20
- Date posted
- 2011-07-11
- Date terminated
- 2012-03-01
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 6 FR FL POWERHOHN AND POWERLINE CATHETER (K051417) | C.R. Bard, Inc. | 2005-06-30 |