Arrow International Recalls FlexTip Plus Epidural Catheterization Kits
Arrow International is recalling FlexTip Plus Epidural Catheterization Kits because the included 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 risk of dural puncture requiring a blood patch, which constitutes a significant injury report under the rubric for Severe recalls.
Plain-English summary
Arrow International Inc is recalling FlexTip Plus Epidural Catheterization Kits, Product Code JC-05400-E. The recall involves 343,105 units distributed to 38 US states, including AK, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY. Specific lot numbers are listed in the agency's recall record.
The recall is due to the potential for various failures with the loss of resistance (LOR) syringes included in the kits. These failures may result in dural puncture, with some instances requiring a blood patch. This is a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
Healthcare providers and facilities that have received these kits should stop using them and contact Arrow International Inc for instructions on return or disposal. Patients who have received epidural anesthesia using these kits should contact their healthcare provider if they experience symptoms such as severe headache, which may indicate a dural puncture.
The recalled product
- Product
- FlexTip Plus Epidural Catheterization Kit, Product Code JC-05400-E
- 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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