FDAClass IIAugust 28, 2024

Medline medical procedure kits labeled as follows: a) recall

Medline medical procedure kits labeled as follows: a) MAJOR BREAST, REF DYNJ905004C; b) MINOR BREAST, REF DYNJ905002B; c) SUCTION MEDI VAC, REF…

Why was Medline medical procedure kits labeled as follows: a) recalled?

A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.

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?

a) REF DYNJ905004C, UDI/DI 40195327316939 (case), 10195327316938 (unit), Lot Numbers: 23CBG213, 23EBI690, 23FBT057, 23GBB635, 23IBA478, 23JBB064; b) REF DYNJ905002B, UDI/DI 40195327316861 (case), 10195327316860 (unit), Lot Numbers: 23ABK521, 23BBG561, 23CBU161, 23EBE334; c) REF DYKM2033, UDI/DI 40193489849241 (case), 10193489849240 (unit), Lot Numbers: 22FMF595, 22HMB247, 22HMD137, 22LMD691, 22LMH566, 23BMG473, 23DMI525, 23FMG464, 23GMH062, 23IMH701, 23KMA183

Product
Medline medical procedure kits labeled as follows: a) MAJOR BREAST, REF DYNJ905004C; b) MINOR BREAST, REF DYNJ905002B; c) SUCTION MEDI VAC, REF…
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
3539 units
Distribution
Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
Recall date
August 28, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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