Bard Access Systems Recalls Non-Sterile GuardIVa Antimicrobial Hemostatic IV Dressing
Bard Access Systems is recalling non-sterile GuardIVa Antimicrobial Hemostatic IV Dressing units that could potentially be used clinically.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential risk of harm (use of non-sterile units clinically) where no specific injuries or illnesses have been reported in the source text, fitting the High severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Bard Access Systems is recalling GuardIVa Antimicrobial Hemostatic IV Dressing, Reference No. FP23AD006, Lot No. ASXHT003. The recall involves 2,532 units of the product.
The reason for the recall is that the units were non-sterile samples which potentially could be used clinically. The product was distributed in the United States to the states of Texas, Oklahoma, Louisiana, and Arkansas.
Healthcare facilities and consumers should stop using the affected product and contact Bard Access Systems for further instructions or a return.
The recalled product
- Product
- GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006.
- Manufacturer
- Bard Access Systems
- Category
- Medical Device — IV Dressing
- Affected units
- 2,532
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 (3)
- Product Code FP23AD006
- Lot No.ASXHT003
- Expiration Date Feb 2016
Distribution
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