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 is defined as unlikely to cause adverse health consequences. The issue is a documentation/labeling error regarding expiration dates, which falls under the 'Low' severity criteria for cosmetic or documentation issues.
Plain-English summary
Bard Access Systems is recalling PowerPICC Solo Catheter Kits, specifically the 4F Maximal Barrier Tray with Microintroducer (Single-Lumen) (Sherlock). 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 due to incorrect expiration dates on the primary labeling of the product. The affected items are identified by Lot No. REYK1761 and Item No. 9194108D. The products were distributed nationwide.
Healthcare providers and facilities should check their inventory for the specific lot and item numbers listed above. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- PowerPICC SOLO2 Catheter 4F Maximal Barrier Tray with Microintroducer (Single-Lumen) (Sherlock) 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 — Catheter
- 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: REYK1761
- Item No. 9194108D
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.
See all 4 products in this recall →Related recalls
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