Agency classClass IIIOur severity:Low FDA (Devices)·Z-2049-2015·Announced 2015-07-15

Bard Access Systems Recalls PowerPICC Solo Catheters for Labeling Errors

Bard Access Systems is recalling PowerPICC Solo Catheter Kits because the primary labels display incorrect expiration dates.

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 the rubric defines as unlikely to cause adverse health consequences. The issue is a documentation/labeling error regarding expiration dates, which fits the 'Low' severity criteria for packaging or documentation issues.

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 Tip Location System (TLS) Stylet 4F Nurse Full Tray with Microintroducer (with Lidocain). These catheters are intended for short or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.

The recall is limited to Lot No. REYK1764, Item No. 9194108. The source text does not specify the number of units affected or the specific distribution locations, though the metadata indicates nationwide distribution.

Healthcare providers and consumers should check their inventory for the specific lot and item numbers listed above. If the product matches the recalled lot, it should not be used. Users should contact Bard Access Systems for further instructions on how to return or dispose of the affected units.

The recalled product

Product: PowerPICC SOLO Catheter with Tip Location System (TLS) Stylet 4F Nurse Full Tray with Microintroducer (with Lidocain) 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: mis-labeling

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: REYK1764
Item No. 9194108

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 →

Same manufacturer · Bard Access Systems

See all →

Moderate
Bard Access Systems Recalls StatLock Catheter Stabilization Devices
FDA (Devices) · 2017-01-18
Moderate
Bard Access Systems Recalls StatLock PICC Plus Devices Due to Missing Identifiers
FDA (Devices) · 2017-01-18
Moderate
Bard Access Systems Recalls MiniLoc Safety Infusion Sets Due to Labeling Errors
FDA (Devices) · 2017-01-18
Moderate
Bard Access Systems Recalls SafeStep Huber Needle Sets Due to Labeling Errors
FDA (Devices) · 2017-01-18
Moderate
Bard Access Systems Recalls PowerPICC Catheter Marketing Brochures
FDA (Devices) · 2015-09-30

Same hazard · mis labeling