Agency classClass IIOur severity:Severe FDA (Devices)·Z-1213-2020·Announced 2020-02-19

Arrow International Recalls Epidural Catheterization Kits Due to Syringe Failure Risk

Arrow International is recalling 343,105 Epidural Catheterization Kits with FlexTip Plus Catheters because the included loss of resistance 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 the source text explicitly states that some cases of dural puncture require a blood patch, which constitutes a significant injury report under the severity rubric.

Plain-English summary

Arrow International Inc is recalling 343,105 units of the Epidural Catheterization Kit with FlexTip Plus Catheter, Product Code TI-05520-EPI. The recall affects lots 71F19E2613 and 71F19F1493. These products were distributed to healthcare facilities in 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 is being conducted because there is a potential for various failures with the loss of resistance (LOR) syringes included in the kits. These failures may result in dural puncture, a condition where the dura mater is accidentally punctured during the procedure. In some cases, patients who experience this complication may require a blood patch to treat the resulting condition.

Healthcare providers and consumers should check their inventory for the specific product code and lot numbers listed above. If the recalled products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations. Patients who have received this product and are experiencing symptoms such as severe headache or neurological changes should contact their healthcare provider immediately.

The recalled product

Product: Epidural Catheterization Kit with FlexTip Plus Catheter, Product Code TI-05520-EPI
Manufacturer: Arrow International Inc
Category: Medical Device — Anesthesia / Catheters
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: 71F19E2613 71F19F1493

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