FDA-Device2015-05-27Class II
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.
DeRoyal Industries Inc
Hazard
The firm received reports of specimen retrieval bags tearing, ripping, and coming apart during use.
Sold states
US Nationwide Distribution
Affected count
5359 units
Manufactured in
200 Debusk Ln, N/A, Powell, TN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1642-2015Don't want to check this manually?
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