Arrow International Recalls Epidural Catheterization Kits Due to Syringe Failure Risk
Arrow International is recalling specific lots of 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 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 risk. This aligns with the rubric for Severe (Score 4) involving significant injury reports or high-risk medical device defects.
Plain-English summary
Arrow International Inc is recalling 343,105 units of the Epidural Catheterization Kit with FlexTip Plus, Open Tip, Single-Port Catheter (Product Code ASK-05502-NY). The recall involves specific lots: 23F19C0385, 23F19G0310, 23F19H0234, 23F19K0248, 23F19F0167, 23F19G0434, and 23F19J0063.
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 cases requiring a blood patch. The FDA has classified this as a Class II recall.
The affected products were distributed to healthcare facilities in 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 lot numbers and stop using these kits.
The recalled product
- Product
- Epidural Catheterization Kit with FlexTip Plus, Open Tip, Single- Port Catheter, Product Code ASK-05502-NY
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- 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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