Bard Access Systems Recalls PowerPICC Provena Catheters Due to Possible Leaks
Bard Access Systems is recalling 53,699 PowerPICC Provena Catheters due to possible leaks at the luer hub extension leg junction.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential leak in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Bard Access Systems Inc. is recalling 53,699 units of PowerPICC Provena Catheters, specifically the 3 Fr. Single lumen and 4 Fr. Dual Lumen models. The recall was initiated because of possible leaks at the luer hub extension leg junction. The affected catheters are packaged in a poly tray with a Tyvek lid within a header bag or breather bag configuration.
The affected products were distributed nationwide in the United States. The recall covers specific product codes and lot numbers, which are listed in the official FDA recall record Z-0536-2018.
Healthcare providers and patients should check their inventory and patient records for the specific lot numbers and product codes listed in the recall notice. If a patient has an affected catheter, they should contact their healthcare provider for instructions on removal or replacement.
The recalled product
- 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.
- Manufacturer
- Bard Access Systems Inc.
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 53,699
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Product Code (Lot/Serial No.): S1274108D (REBN2334)
- S9274108D (REBN2336)
- S3274108PD (REBP1471)
- S3274335 (REBP1580)
- S3274355 (REBP1581)
- S3274355P (REBP1582)
- S3274335P (REBP1583)
- S1274108PD (REBP1971)
- S1274108 (REBQ1883)
- S3274355 (REBQ1884)
- S3274335 (REBQ1885)
- S3274108D (REBQ1886)
- S1274108D (REBQ1887)
- S9274108PD (REBQ1888)
- S0274108PD (REBQ1889)
- S3274335P (REBQ1890)
- S1274118 (REBQ1891)
- S9274108D (REBQ1892)
- S1274108D (REBR0160)
- S1274108D (REBN1883)
Distribution
Distributed nationwide across the United States.
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