Arrow International Recalls FlexTip Plus Combined Spinal Epidural Catheterization Kits
Arrow International is recalling FlexTip Plus Combined Spinal Epidural Catheterization Kits due to potential syringe failures that could cause 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 FlexTip Plus Combined Spinal Epidural Catheterization Kits, Product Code NYU-05500-1. 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 23F19A0245 and 23F19G0253.
The recall was initiated 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 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. Patients who have received these kits should contact their healthcare provider if they experience any complications.
The recalled product
- Product
- FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code NYU-05500-1
- 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: 23F19A0245 23F19G0253
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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