Recall Z-0536-2018— Bard Access Systems Inc.
Class II · Terminated
Class II FDA medical device recall by Bard Access Systems Inc., initiated 2017-12-28, terminated 2021-06-14. It names one FDA 510(k) clearance: K162443. Product: PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a poly tray with Tyvek lid within a header bag configuration or a breather bag configuration.. Reason: Possible leaks on the 3 Fr. Single lumen and 4 Fr. Dual lumen PowerPICC catheters at the luer hub extension leg junction..
- Recalling firm
- Bard Access Systems Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-12-28
- Terminated
- 2021-06-14
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a poly tray with Tyvek lid within a header bag configuration or a breather bag configuration.
Reason for recall
Possible leaks on the 3 Fr. Single lumen and 4 Fr. Dual lumen PowerPICC catheters at the luer hub extension leg junction.
Data sourced from openFDA. This site is unofficial and independent of the FDA.