Bard Access Systems Recalls PowerPICC Solo Catheter Kits for Labeling Errors
Bard Access Systems is recalling PowerPICC Solo Catheter Kits because the primary labels contain incorrect expiration dates.
What this means for you
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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/labeling error regarding expiration dates.
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 4F Maximal Barrier Tray with Microintroducer, specifically Lot No. REYK1763 and Item No. 1194108D. 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 on the kits displays incorrect expiration dates. The source text does not specify the nature of the discrepancy, such as whether the dates are too early or too late, nor does it indicate if the products were distributed past their actual expiration dates.
The recall is classified as Class III by the U.S. Food and Drug Administration, which indicates that the use of or exposure to the violative product is not likely to cause adverse health consequences. The products were distributed nationwide. Healthcare facilities and consumers should check their inventory for the specific lot and item numbers listed and stop using the affected kits if found.
The recalled product
- Product
- PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F 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: REYK1763
- Item No. 1194108D
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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