Agency classClass IIOur severity:Severe FDA (Devices)·Z-1211-2020·Announced 2020-02-19

Arrow International Recalls FlexTip Plus Combined Spinal Epidural Catheterization Kits

Arrow International is recalling FlexTip Plus Combined Spinal Epidural Catheterization Kits due to potential syringe failures that could cause 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 can result in dural puncture and the need for a blood patch, which constitutes a significant injury risk.

Plain-English summary

Arrow International Inc is recalling FlexTip Plus Combined Spinal Epidural Catheterization Kits, Product Code NYU-05500-1. The recall involves 343,105 units 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 affected lots are 23F19A0245 and 23F19G0253.

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 could result in dural puncture, with some instances requiring a blood patch. The agency has classified this as a Class II recall.

Healthcare providers and facilities should check their inventory for the specific product code and lot numbers listed above. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. Patients who have received these kits should contact their healthcare provider if they experience any complications.

The recalled product

Product: FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code NYU-05500-1
Manufacturer: Arrow International Inc
Category: Medical Device — Catheterization Kit
Hazard: dural-puncture
device-failure
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: 23F19A0245 23F19G0253

Distribution

Distributed in 37 states:

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 →

Same manufacturer · Arrow International Inc

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Same hazard · dural puncture