Access Scientific Recalls Mislabeled POWERWAND Safety Introducer Catheters
Access Scientific is recalling 160 units of the POWERWAND Safety Introducer with Extended Dwell Catheter because the product is mislabeled.
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 labeling error without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Access Scientific is recalling the POWERWAND Safety Introducer with Extended Dwell Catheter, catalog number 92006. This medical device is used to gain access to the vascular system to sample blood and administer fluids intravenously.
The recall was initiated because the product is mislabeled. The source text does not specify the nature of the labeling error or any associated health risks.
A total of 160 units were distributed in Michigan and Texas. The affected lot number is I666473. The source text does not provide specific instructions for consumers or healthcare providers regarding the return or disposal of the recalled units.
The recalled product
- Product
- POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006. Used to gain access to the vascular system to sample blood and administer fluids intravenously.
- Manufacturer
- Access Scientific Inc
- Category
- Medical Device — Vascular Access
- Hazard
- Affected units
- 160
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 no. I666473
Distribution
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