FDAClass IIDecember 11, 2024

MEDLINE convenience kits labeled as: 1) BREAST BIOPSY recall

MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BREAST BIOPSY PACK-LF, REF DYNJ0842590G; 3) TREATMENT ROOM PACK…

Why was MEDLINE convenience kits labeled as: 1) BREAST BIOPSY recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

1) REF DYNJ0160598C, UDI/DI 10195327304270 (each) 40195327304271 (case), Lot Numbers: 23ADA376, 23DDA345, 23ADB824; 2) REF DYNJ0842590G, UDI/DI 10195327286439 (each) 40195327286430 (case), Lot Numbers: 23HDA481, 23DDB914, 23DDA319; 3) REF DYNJ41473G, UDI/DI 10193489983982 (each) 40193489983983 (case), Lot Numbers: 22KMD254, 23KBD038, 23EMK120, 23CMA828; 4) REF DYNJ41473I, UDI/DI 10195327584931 (each) 40195327584932 (case), Lot Numbers: 24DBF911; 5) REF DYNJ44148G, UDI/DI 10195327412487 (each) 40195327412488 (case), Lot Numbers: 23EBV384, 23JBW504, 23KBG481; 6) REF DYNJ81776A, UDI/DI 10195327515881 (each) 40195327515882 (case), Lot Numbers: 23LBN724, 24CBH515; 7) REF DYNJ82691, UDI/DI 10195327202934 (each) 40195327202935 (case), Lot Numbers: 23GMI494, 23JMH927

Product
MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BREAST BIOPSY PACK-LF, REF DYNJ0842590G; 3) TREATMENT ROOM PACK…
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
980 units
Distribution
US Nationwide distribution.
Recall date
December 11, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls