Arrow International Recalls FlexTip Plus Epidural Catheterization Kits
Arrow International is recalling FlexTip Plus Epidural Catheterization Kits because the included 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (dural puncture) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Arrow International Inc is recalling 343,105 units of the FlexTip Plus Epidural Catheterization Kit, Product Code YC-02220. The recall involves specific lots: 13F19B0340, 13F19E0025, 13F19G0069, 13F19H0066, 13F19K0137, and 13F19K0582.
The recall was initiated because there is a 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 products were distributed to the following US states: 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. Healthcare providers should check their inventory for the affected product code and lot numbers.
The recalled product
- Product
- FlexTip Plus Epidural Catheterization Kit, Product Code YC-02220
- 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: 13F19B0340 13F19E0025 13F19G0069 13F19H0066 13F19K0137 13F19K0582
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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