MEDLINE INDUSTRIES, LP - Northfield recalls Medline Convenience kits used for various procedures: 1) LARGE BIOPSY PACK NTX, Model Number: DYNJ68393A; 2) SOFT TISSU…

Recall date

March 3, 2025

Source

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

Recall number

Z-1594-2025

FDA classification

Class II

Brand / firm

MEDLINE INDUSTRIES, LP - Northfield

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

Why it was recalled

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

What was recalled

Medline Convenience kits used for various procedures: 1) LARGE BIOPSY PACK NTX, Model Number: DYNJ68393A; 2) SOFT TISSUE BIOPSY PACK, Model Number: DYNJ81441B; 3) BILAT TESTICULAR SPERM EXTRACT, Model Number: DYNJ68303; 4) PROCEDURE MINEURE BJC-LF, Model Number: DYNJ41678B; 5) PROCEDURE MINEURE BJC-LF, Model Number: DYNJ41678B; 6) PHLEBECTOMY PACK, Model Number: DYNJ55215G; 7) BIOPSY/DRAINAGE TRAY-LF, Model Number: DYNJ30078D; 8) CAT BIOPSY PACK, Model Number: DYNJ62968; 9) ABLATION/DRAINAGE PACK, Model Number: DYNJ53658D; 10) BIOPSY KIT, Model Number: DYNJ61130B