Bard Access Systems Recalls PowerPICC Solo Catheter Kits for Labeling Errors
Bard Access Systems is recalling PowerPICC Solo Catheter Kits because they have incorrect expiration dates on the primary labeling.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The issue is a labeling error regarding expiration dates, which falls under the 'Low' severity criteria for documentation or packaging-only problems.
Plain-English summary
Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling. The affected products are the PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tray with Microintroducer, specifically Lot No. REYK1762 and Item No. 1295108D.
These catheters are intended for short or long-term peripheral access to the central venous system for intravenous therapy and blood sampling. The recall was initiated because the primary labeling displays incorrect expiration dates, which could affect the determination of product viability.
The recall involves nationwide distribution. Healthcare facilities and consumers should stop using the affected lots and contact Bard Access Systems for further instructions or replacement.
The recalled product
- Product
- PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tray with Microintroducer The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
- Manufacturer
- Bard Access Systems
- Category
- Medical Device — Catheters
- Hazard
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 (2)
- Lot No: REYK1762
- Item No. 1295108D
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Bard Access Systems under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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