MEDLINE INDUSTRIES, LP - Northfield recalls Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO D

Recalled March 26, 2025 · FDA recall Z-1364-2025 · MEDLINE INDUSTRIES, LP - Northfield

Hazard

Potential breach in pouch packaging which could lead to loss of sterility. · FDA Class II

Units

1,490 units

Sold at

US Nationwide distribution.

Description

Potential breach in pouch packaging which could lead to loss of sterility.

Product

Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,UNIVERSAL II,SIRUS,7/CS; PACK,LAPAROTOMY,NO GOWN,10/CS; PACK,CYSTOSCOPY,PK VI,14/CS; PACK,CYSTOSCOPY,PK VI,14/CS; PACK,OB III,GRADUATED UNDERBUTTOCK,6/CS; PACK,LAVH,AURORA,4/CS. Sterile surgical drape.

Manufacturer(s)

MEDLINE INDUSTRIES, LP - Northfield

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →