Arrow International Recalls Vascular Catheter Introduction Kits Due to Flaring Sheaths
Arrow International Inc is recalling 215,703 vascular catheter introduction kits nationwide because complaints were received regarding peel away sheaths flaring.
What this means for you
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 is classified as FDA Class II, and the source text describes a functional defect (flaring sheaths) in a medical device without reporting specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Arrow International Inc is recalling 215,703 units of vascular catheter introduction kits. These products are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, and power injection of contrast media. The recall is being conducted due to complaints that the peel away sheaths on the kits are flaring.
The affected products were distributed nationwide. The recall includes specific material codes such as ASK-01663-MST, ASK-04001-DU4, and PI-01351-LS. The U.S. Food and Drug Administration has classified this recall as Class II, which indicates 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.
Healthcare facilities and consumers should stop using the affected vascular catheter introduction kits and contact Arrow International Inc for instructions on how to return the products for a refund or replacement.
The recalled product
- Product
- Vascular catheter introduction kit The PICC is indicated for short or long term peripheral access to the central Venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media.
- Manufacturer
- Arrow International Inc
- Hazard
- Affected units
- 215,703
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 (19)
- Material # ASK-01663-MST
- ASK-04001-DU4
- ASK-04001-DU5
- PI-01351-LS
- PI-01351-LS5
- PI-01351-SS
- PI-01552-LS
- PI-01552-LS5
- PI-01552-SS
- PL-05041
- PL-05052
- PR-05041
- PR-05041-T
- PR-05042
- ASK-01663-MST
- PI-01451-LS
- PI-01451-LS5
- PI-01451-SS
- PI-0-1552-LS
Distribution
Distributed nationwide across the United States.
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