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 consistent with the 'Severe' rubric criteria.
Plain-English summary
Arrow International Inc is recalling FlexTip Plus Epidural Catheterization Kits, Product Code TI-05501-ME. The recall involves 343,105 units distributed to 38 U.S. states. The specific lot numbers affected are 71F19A1324, 71F19C2255, 71F19E3165, 71F19H1740, 71F19K0132, 71F19B0614, 71F19C2567, 71F19G0092, 71F19H1742, 71F19K0134, 71F19C2254, 71F19E0766, 71F19G1018, 71F19H2570, and 71F19L0033.
The recall is being conducted because there is the potential for various failures with the loss of resistance (LOR) syringes included in the kits. These failures could result in dural puncture, with some instances requiring a blood patch. The agency has classified this as a Class II recall.
Healthcare providers and facilities should check their inventory for the affected product code and lot numbers. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. Patients who have received this product should contact their healthcare provider if they experience any adverse effects.
The recalled product
- Product
- FlexTip Plus Epidural Catheterization Kit, Product Code TI-05501-ME
- 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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