Arrow Kits with Medtronic Syringes Recalled for Compromised Sterility
Arrow International Inc. is recalling Arrow Kits containing Medtronic Covidien 0.9% Sodium Chloride Flush Syringes due to compromised sterility of the outer barrel.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves compromised sterility of a medical device, which poses a significant risk of infection and potential hospitalization, meeting the criteria for a Severe rating.
Plain-English summary
Arrow International Inc. is recalling Arrow Kits that were packaged with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes. The recall was initiated because the sterility of the outer barrel of the syringes was compromised.
The affected products were distributed nationwide and internationally. The recall involves 73,714 units. Specific lot numbers and product codes are listed in the official FDA recall record Z-2825-2015.
Healthcare facilities and consumers should stop using these specific kits and syringes immediately. Users should check their inventory for the affected lot numbers and contact Arrow International Inc. for instructions on returning or disposing of the recalled items.
The recalled product
- Product
- Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Syringes
- Affected units
- 73,714
Distribution
Distributed nationwide across the United States.
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