Arrow International Recalls PICC and VPS Access Kits with Touhy Borst Catheters
Arrow International is recalling PICC and VPS Access Kits with Touhy Borst catheters due to saline leakage from unsecured connections. No injuries have been reported.
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 is classified as FDA Class II. Per the rubric, risk-of-harm products where injury has not yet been reported are assigned a score of 3 (High).
Plain-English summary
Arrow International, Inc. is recalling PICC Kits and VPS Access Kits with Touhy Borst Component Catheters. The recall involves 92,902 units that were distributed nationwide in the US and internationally to Canada.
The recall is being conducted because of saline leakage from unsecured connections between the Touhy Borst adaptor and the hub of the catheter. The source text explicitly states that no injuries have been reported.
Healthcare providers and consumers should check their inventory for the specific material and batch numbers listed in the official recall notice. If the product is found, it should be removed from use and returned to the manufacturer or supplier for further instructions.
The recalled product
- Product
- Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component Catheter, Intravascular, Therapeutic, Ultrasound, Long Term Greater than 30 Days
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Affected units
- 92,902
Distribution
Distributed nationwide across the United States.
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