Recall Z-0627-2025— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-0627-2025
Creator: U.S. Food and Drug Administration
Published: 2024-10-09

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2024-10-09. FDA's recall record names no specific 510(k) clearance for this event. Product: MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BREAST BIOPSY PACK-LF, REF DYNJ0842590G; 3) TREATMENT ROOM PACK, REF DYNJ41473G; 4) TREATMENT ROOM PACK, REF DYNJ41473I; 5) BREAST BIOPSY PACK, REF DYNJ44148G; 6) PRX BREAST PACK, REF DYNJ81776A; 7) TAMPONADE, REF DYNJ82691. Reason: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2024-10-09
Firm location: Northfield, IL, United States

Product description

MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BREAST BIOPSY PACK-LF, REF DYNJ0842590G; 3) TREATMENT ROOM PACK, REF DYNJ41473G; 4) TREATMENT ROOM PACK, REF DYNJ41473I; 5) BREAST BIOPSY PACK, REF DYNJ44148G; 6) PRX BREAST PACK, REF DYNJ81776A; 7) TAMPONADE, REF DYNJ82691

Reason for recall

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

Data sourced from openFDA. This site is unofficial and independent of the FDA.