Arrow International Recalls Epidural Catheterization Kits Due to Syringe Failure Risk
Arrow International Inc is recalling 343,105 Epidural Catheterization Kits because the included loss of resistance syringes may fail, potentially causing dural puncture.
What this means for you
Illness, injury, or structural failure has been reported. 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 a medical device defect that can lead to dural puncture, a significant injury requiring medical intervention such as a blood patch.
Plain-English summary
Arrow International Inc is recalling 343,105 units of the Epidural Catheterization Kit, Product Code FR-05501-04. The recall involves specific lots of the product, including 71F19B0678, 71F19C1428, and 71F19E1149, among others. The affected products were distributed to healthcare facilities in 37 US states, including California, Texas, and New York.
The recall was initiated because there is a potential for various failures with the loss of resistance (LOR) syringes included in the kits. These failures could result in dural puncture, a condition where the protective membrane surrounding the spinal cord is accidentally pierced. In some cases, patients who experience this complication may require a blood patch to resolve the issue.
Healthcare providers and consumers should check their inventory for the specific lot numbers listed in the recall notice. If you have used or possess these kits, you should contact Arrow International Inc for further instructions on how to return the product or obtain a replacement. Do not use the affected kits until further notice.
The recalled product
- Product
- EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-04
- Manufacturer
- Arrow International Inc
- Affected units
- 343,105
Distribution
Part of a larger recall action
This product is one of 49 recalled by Arrow International Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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