Arrow International Recalls FlexTip Plus Combined Spinal Epidural Catheterization Sets
Arrow International Inc is recalling FlexTip Plus Combined Spinal Epidural Catheterization Sets because the included loss of resistance syringes may fail, potentially causing dural puncture.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 under the severity rubric.
Plain-English summary
Arrow International Inc is recalling FlexTip Plus Combined Spinal Epidural Catheterization Sets, Product Code AA-05400-B. 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 71F19E2457, 71F19G0988, 71F19H1281, 71F19K2009, 71F19F1658, 71F19G2371, and 71F19J1079.
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 instances requiring a blood patch. The FDA has classified this as a Class II recall.
Healthcare providers and facilities should stop using the affected products and contact Arrow International Inc for further instructions on the recall process.
The recalled product
- Product
- FlexTip Plus Combined Spinal Epidural Catheterization Set, Product Code AA-05400-B
- Manufacturer
- Arrow International Inc
- Affected units
- 343,105
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.
See all 49 products in this recall →Related recalls
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