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 343,105 units of the FlexTip Plus Epidural Catheterization Kit, Product Code ASK-17019-MSC. The recall involves specific lots: 13F18K0094, 13F19B0335, 13F19C0594, 13F19G0068, 13F19G0591, and 13F19J0119.
The recall was initiated because there is a 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.
The products were distributed to healthcare facilities in the following US states: 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. Healthcare providers should stop using the affected kits and contact Arrow International for instructions on returning the products.
The recalled product
- Product
- FlexTip Plus Epidural Catheterization Kit, Product Code ASK-17019-MSC
- 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: 13F18K0094 13F19B0335 13F19C0594 13F19G0068 13F19G0591 13F19J0119
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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