Bard StatLock IV Premium Catheter Stabilization Device Recalled for Sizing Error
Bard Access Systems is recalling 4,500 units of StatLock IV Premium Catheter Stabilization Devices because they may contain incorrectly sized retainer clips.
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, which typically corresponds to a Moderate severity score (2) when no specific hospitalizations or serious injuries are reported in the source text.
Plain-English summary
Bard Access Systems Inc. is recalling 4,500 units of the StatLock IV Premium Catheter Stabilization Device, product code IV0570. The recall affects Lot Number JUAQF675, which has an expiration date of 2/28/2019. The devices are sterile and packaged in single units within Tyvek-to-film pouches, distributed in cartons of 25 or cases of 250.
The recall was initiated because the devices may contain an incorrectly sized retainer clip. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The affected products were distributed nationwide and internationally to Canada. The source text notes that there were no government, VA, or military consignees. Users should stop using the affected devices and contact Bard Access Systems for further instructions.
The recalled product
- Product
- StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film pouches, the product is distributed in cartons containing 25 devices and cases containing 250 devices.
- Manufacturer
- Bard Access Systems Inc.
- Hazard
- Affected units
- 4,500
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 (2)
- Lot Number JUAQF675
- Exp 2/28/2019
Distribution
Distributed nationwide across the United States.
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