Espiner Medical Ltd recalls Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:5060358120367) Product Usage: Tis…

Recall date

June 20, 2018

Source

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

Recall number

Z-0444-2019

FDA classification

Class II

Brand / firm

Espiner Medical Ltd

Sold / distributed

US Nationwide in the states of CA, IL, MT, NC, NJ,

Why it was recalled

Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000ml

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

What was recalled

Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:5060358120367) Product Usage: Tissue Retrieval sac made from ripstop nylon. The EMP160ECO-US-5 is a semi-automatic sac, which incorporates a monofilament drawstring around the mouth of the bag, so that it can be pulled closed and removed from the body cavity.