Agency classClass IIOur severity:Severe FDA (Devices)·Z-1196-2020·Announced 2020-02-19

Arrow International Recalls Pediatric Epidural Catheterization Sets Due to Syringe Failure Risk

Arrow International is recalling FlexTip Plus Epidural Catheterization Sets for pediatric lumbar placement 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. The hazard involves a medical device failure leading to dural puncture, a significant injury that may require a blood patch, fitting the rubric for significant injury reports or high-risk medical device defects.

Plain-English summary

Arrow International Inc is recalling 343,105 units of the FlexTip Plus Epidural Catheterization Set for Pediatric Lumbar Placement, Product Code EC-05520-P. The recall affects specific lots: 71F19B2227, 71F19E1297, 71F19G1231, 71F19G2158, 71F19H2674, and 71F19J0430.

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 instances requiring a blood patch.

The products were 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. Healthcare providers and facilities should check their inventory for the affected product code and lot numbers and stop using these kits if they match the recall criteria.

The recalled product

Product: FlexTip Plus Epidural Catheterization Set for Pediatric Lumbar Placement, Product Code EC-05520-P
Manufacturer: Arrow International Inc
Category: Medical Device — Epidural Catheter
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: 71F19B2227 71F19E1297 71F19G1231 71F19G2158 71F19H2674 71F19J0430

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