Arrow International Recalls FlexTip Plus Combined Spinal Epidural Catheterization Kits
Arrow International is recalling FlexTip Plus Combined Spinal 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 requiring a blood patch, which constitutes a significant injury risk.
Plain-English summary
Arrow International Inc is recalling FlexTip Plus Combined Spinal Epidural Catheterization Kits, Product Code ASK-05560-TG1. The recall involves 343,105 units 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 affected lots are 23F19A0154, 23F19C0273, 23F19F0029, 23F19G0360, and 23F19M0226.
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. The FDA has classified this as a Class II recall.
Healthcare facilities and consumers should stop using the affected products and contact Arrow International Inc for further instructions or a return.
The recalled product
- Product
- FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-TG1
- 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: 23F19A0154 23F19C0273 23F19F0029 23F19G0360 23F19M0226
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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