DeRoyal Industries Inc recalls DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use specimen…

Recall date

April 17, 2015

Source

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

Recall number

Z-1642-2015

FDA classification

Class II

Brand / firm

DeRoyal Industries Inc

Sold / distributed

US Nationwide Distribution

Why it was recalled

The firm received reports of specimen retrieval bags tearing, ripping, and coming apart during use.

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

What was recalled

DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use specimen retrieval bag indicated for use in laparoscopic procedures to capture and remove organs or tissue from the body cavity.