Arrow International Recalls 10 cc Luer-Slip Loss of Resistance Syringes
Arrow International Inc is recalling 10 cc Luer-Slip Loss of Resistance Syringes due to potential failures that could result in 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 with a potential for dural puncture requiring a blood patch, which constitutes a significant injury report under the severity rubric.
Plain-English summary
Arrow International Inc is recalling 10 cc Luer-Slip Loss of Resistance Syringes, Product Code LR-05501. The recall covers 343,105 units distributed across 37 U.S. 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 LOR (loss of resistance) syringes included in the kits. These failures could result in dural puncture, with some cases also requiring a blood patch.
Healthcare providers and facilities should check their inventory for the specific lot numbers listed in the recall notice and stop using the affected syringes. Consumers should contact their healthcare provider if they have been administered these syringes and are experiencing symptoms consistent with dural puncture.
The recalled product
- Product
- 10 cc Luer-Slip Loss of Resistance Syringe, Product Code LR-05501
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Syringes
- 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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