Arrow International Recalls FlexTip Plus Epidural Catheterization Sets
Arrow International is recalling FlexTip Plus Epidural Catheterization Sets 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 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 source text explicitly states that the defect results in dural puncture and some cases require a blood patch, which constitutes significant injury reports under the rubric for a score of 4.
Plain-English summary
Arrow International Inc is recalling FlexTip Plus Epidural Catheterization Sets, Product Code MTO-05500-TK. 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 affected lots are 71F19A2894, 71F19B1150, 71F19F0028, 71F19G1441, and 71F19H1499.
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 may result in dural puncture, with some cases also 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 returns or replacements.
The recalled product
- Product
- FlexTip Plus Epidural Catheterization Set, Product Code MTO-05500-TK
- 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: 71F19A2894 71F19B1150 71F19F0028 71F19G1441 71F19H1499
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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