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 ASK-05400-CA1. 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 affected lots are 13F19B0343, 13F19B0501, 13F19E0698, and 13F19H0470.
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 check their inventory for the specific product code and lot numbers listed above. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05400-CA1
- Manufacturer
- Arrow International Inc
- Affected units
- 343,105
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lots: 13F19B0343 13F19B0501 13F19E0698 13F19H0470
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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