Arrow FlexTip Plus Epidural Catheterization Set Recalled for Syringe Failures
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 recall is classified as FDA Class II and involves a medical device defect that results in dural puncture, a significant injury requiring medical intervention (blood patch), meeting the criteria for a Severe rating.
Plain-English summary
Arrow International Inc is recalling 343,105 units of the FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-B. The recall involves specific lots 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 was initiated because there is the potential for various failures with the loss of resistance (LOR) syringes included in the kits. These failures can result in dural puncture, with some instances requiring a blood patch.
Healthcare providers and consumers should stop using the affected products immediately. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- FlexTip Plus Epidural Catheterization Set, Product Code JC-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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Similar recalls
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