Arrow International Recalls FlexTip Plus Epidural Catheterization Kits
Arrow International is recalling FlexTip Plus Epidural Catheterization Kits due to potential syringe failures that could cause dural puncture.
What this means for you
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 is classified as FDA Class II. The hazard involves a risk of harm (dural puncture) where specific injury counts are not reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Arrow International Inc is recalling FlexTip Plus Epidural Catheterization Kits, Product Code MP-17019-TKP. 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.
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 and facilities should stop using the affected lots and contact Arrow International for further instructions. The affected lot numbers are 23F19C0216, 23F19F0037, 23F19G0368, 23F19J0089, 23F19K0199, 23F19M0018, 23F19E0350, 23F19F0269, 23F19H0131, 23F19J0208, and 23F19L0230.
The recalled product
- Product
- FlexTip Plus Epidural Catheterization Kit, Product Code MP-17019-TKP
- 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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