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.
Reported: February 14, 2018 Initiated: December 28, 2017 #Z-0536-2018
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.
Details
- Recalling Firm
- Bard Access Systems Inc.
- Units Affected
- 53,699 units total
- Distribution
- Distribution US nationwide.
- Location
- Salt Lake City, UT
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Bard Access Systems Inc.. Units affected: 53,699 units total.
Why was this product recalled? ▼
Possible leaks on the 3 Fr. Single lumen and 4 Fr. Dual lumen PowerPICC catheters at the luer hub extension leg junction.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 14, 2018. Severity: Moderate. Recall number: Z-0536-2018.
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