Agency classClass IIOur severity:Severe FDA (Devices)·Z-1174-2020·Announced 2020-02-19

Arrow International Recalls FlexTip Plus Epidural Catheterization Kits

Arrow International is recalling FlexTip Plus 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 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 343,105 units of the FlexTip Plus Epidural Catheterization Kit, Product Code ASK-02220-SRH. The recall involves specific lots: 13F19F0303, 13F19G0072, and 13F19L0140. 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.

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 may result in dural puncture, with some instances requiring a blood patch. The FDA has classified this recall as Class II, indicating that use of the product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and facilities that have received these kits should stop using them and contact Arrow International Inc. for instructions on return or replacement. Consumers should not use these medical devices at home, as they are intended for professional medical use.

The recalled product

Product: FlexTip Plus Epidural Catheterization Kit, Product Code ASK-02220-SRH
Manufacturer: Arrow International Inc
Category: Medical Device — Epidural Catheterization
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: 13F19F0303 13F19G0072 13F19L0140

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

See all →

High
Arrow Arterial Kits Recalled Due to Open Packaging Seals
FDA (Devices) · 2024-10-02
Severe
Intra-Aortic Balloon Catheter Kit Recalled for Inflation and Structural Defects
FDA (Devices) · 2024-06-12
Severe
Arrow Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect
FDA (Devices) · 2024-06-12
Severe
Arrow UltraFlex Intra-Aortic Balloon Catheter Kit Recalled for Device Malfunction
FDA (Devices) · 2024-06-12
Severe
ARROW QuickFlash Radial Artery Catheters Recalled for Defective Component
FDA (Devices) · 2024-03-27

Same hazard · dural puncture