Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Versa - Kath Mini Kit Recalled by Epimed International, Inc. Due to Mislabeling

Date: June 18, 2019
Company: Epimed International, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Epimed International, Inc. directly.

Affected Products

Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 311291155 for epidural or caudal anesthesia

Quantity: 200 kits

Why Was This Recalled?

Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included.

Where Was This Sold?

This product was distributed to 8 states: AR, CA, FL, ID, NY, OK, TX, WA

Affected (8 states)Not affected

About Epimed International, Inc.

Epimed International, Inc. has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report