Arrow Recalls Percutaneous Sheath Introducer Sets Due to Packaging Damage
Arrow International Inc. is recalling Super Arrow-Flex Percutaneous Sheath Introducer Sets because packaging damage may compromise sterility, posing a potential infection risk.
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 risk-of-harm product (potential infection from non-sterile medical devices) where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
Arrow International Inc. has issued a recall for Super Arrow-Flex Percutaneous Sheath Introducer Sets (reference numbers CL-07035, CL-07635, CL-07735, and CL-07835). The recall involves 56,521 units that were distributed nationwide to 45 states. These medical devices are intended for use in hospital catheterization laboratories for the percutaneous introduction of various devices into veins and/or arteries.
The recall was initiated due to potential packaging damage, which means the sterility of the products cannot be guaranteed. If non-sterile product is used, there is a potential for infection to occur. The source text does not report any specific illnesses or injuries associated with the use of these devices.
Healthcare facilities and distributors should stop using the affected products and contact Arrow International Inc. for further instructions on how to return or dispose of the recalled items.
The recalled product
- Product
- Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07635 or CL-07735 or CL-07835 Super Arrow-Flex Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port and Radiopaque Tip Marker Band Contents: 1: . . . . . . . . . Sheath*: ***…
- Manufacturer
- Arrow International Inc
- Affected units
- 56,521
Distribution
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