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.
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 involves a medical device defect that can lead to dural puncture and the need for a blood patch, which constitutes a significant injury report under the rubric for Severe recalls.
Plain-English summary
Arrow International Inc is recalling FlexTip Plus Combined Spinal Epidural Catheterization Kits, Product Code ASK-05560-WH. The recall involves 343,105 units distributed to 38 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 is issued 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 affected lots are 13F18L0892, 13F19C0478, 13F19E0433, 13F19K0051, 13F19B0588, 13F19D0327, 13F19H0209, and 13F19L0079.
Healthcare providers and facilities should check their inventory for these specific product codes and lot numbers. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-WH
- 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.
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