Versa - Kath Mini Kit recalled over labeling errors

Recall date

June 18, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Epimed International, Inc. recalls 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) 108…

Recall number

Z-2068-2019

FDA classification

Class II

Brand / firm

Epimed International, Inc.

Sold / distributed

Distribution in US states of CA, FL, OK, AR, WA, TX, ID, NY, South Africa, and Mexico

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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