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 involves a medical device defect that can cause dural puncture requiring a blood patch, which constitutes a significant injury report under the rubric for Severe severity.
Plain-English summary
Arrow International Inc is recalling FlexTip Plus Epidural Catheterization Kits, Product Code ASK-05501-SH. The recall involves 343,105 units distributed to 37 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.
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 cases requiring a blood patch.
Healthcare providers should stop using the affected lots immediately. The affected lot numbers are 23F19A0240, 23F19G0305, 23F19J0292, 23F19L0414, 23F19E0112, 23F19G0496, and 23F19K0152.
The recalled product
- Product
- FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05501-SH
- 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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- SevereArrow International Recalls FlexTip Plus Epidural Catheterization Kits
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