Bard Access Systems Recalls StatLock PICC Plus Devices Due to Missing Identifiers
Bard Access Systems is recalling StatLock PICC Plus Crescent Foam devices because some pouches lack unique product identifiers like lot numbers.
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 classified as FDA Class II and involves a documentation issue (missing identifiers) without reported injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Bard Access Systems has announced a voluntary field action for StatLock PICC Plus Crescent Foam catheter stabilization devices. The recall affects 30,000 units distributed worldwide and across the United States.
The action was taken because some single unit pouches were released without unique product identifiers, including the product code, lot number, and expiration date. The affected lot numbers are JUZGF345 and JUAQF020.
These devices are suture-free stabilization devices used for peripherally inserted central catheters (PICCs) and central venous catheters (CVCs). The source text does not specify specific consumer actions or report any illnesses or injuries associated with this recall.
The recalled product
- Product
- StatLock¿ PICC Plus Crescent Foam. Product Code: VPPCSP & VPPCSPCE. 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…
- Manufacturer
- Bard Access Systems
- Hazard
- Affected units
- 30,000
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: JUZGF345 & JUAQF020
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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