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 is classified as FDA Class II and involves a risk of dural puncture requiring a blood patch, which aligns with the rubric for Severe severity involving significant injury reports or high-risk medical device defects.
Plain-English summary
Arrow International Inc is recalling FlexTip Plus Combined Spinal Epidural Catheterization Kits, Product Code ASK-05500-BID. 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 recall is being conducted 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 cases requiring a blood patch. The affected lots are 23F19E0337, 23F19J0065, 23F19K0100, 23F19L0218, 23F19H0048, 23F19J0314, 23F19K0303, and 23F19M0007.
Healthcare providers and facilities should stop using the affected kits and contact Arrow International Inc for instructions on return or replacement. Patients who have received these kits should consult their healthcare provider if they experience symptoms related to dural puncture.
The recalled product
- Product
- FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05500-BID
- 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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