Bard Access Systems Recalls StatLock Catheter Stabilization Devices
Bard Access Systems is voluntarily recalling StatLock CV Plus catheter stabilization devices because some pouches lack unique product identifiers.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary field action for missing documentation (product identifiers) on a medical device, which aligns with the rubric for minor labeling or documentation issues.
Plain-English summary
Bard Access Systems is conducting a voluntary field action for StatLock CV Plus catheter stabilization devices. The recall affects specific units packaged in single unit pouches that were released without unique product identifiers, such as product codes, lot numbers, or expiration dates.
The affected product is the StatLock CV Plus w/Pigtail, with product codes CV0220CE and CV0220. These are suture-free stabilization devices used for central venous catheters. The recall covers 14,500 units distributed worldwide and nationwide in the US. The specific lot numbers involved are JUZKF615 and JUAPF369.
Healthcare facilities and consumers should check their inventory for these specific product codes and lot numbers. If units are found without the required unique product identifiers, they should be removed from use and returned to the manufacturer or contact Bard Access Systems for instructions.
The recalled product
- Product
- StatLock¿ CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on configuration, there are either 25 or 50 pouches per carton and 10 cartons per case. Other configurations may contain…
- Manufacturer
- Bard Access Systems
- Hazard
- Affected units
- 14,500
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 (1)
- Lot Number: JUZKF615 & JUAPF369.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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