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 medical device defect that can result in dural puncture and the need for a blood patch, which constitutes a significant injury risk.
Plain-English summary
Arrow International Inc. is recalling 343,105 units of the FlexTip Plus Epidural Catheterization Kit, Product Code ASK-02220-SRH. The recall involves specific lots: 13F19F0303, 13F19G0072, and 13F19L0140. The products were 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 was initiated because there is the potential for various failures with the LOR (loss of resistance) syringes included in the kits. These failures may result in dural puncture, with some instances requiring a blood patch. The FDA has classified this recall as Class II, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and facilities that have received these kits should stop using them and contact Arrow International Inc. for instructions on return or replacement. Consumers should not use these medical devices at home, as they are intended for professional medical use.
The recalled product
- Product
- FlexTip Plus Epidural Catheterization Kit, Product Code ASK-02220-SRH
- 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: 13F19F0303 13F19G0072 13F19L0140
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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