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FDAFDA · Food and drugs·Recall number Z-2707-2024

Medline medical procedure kits labeled as follows: a) MAJOR BREAST, REF DYNJ905004C; b) MINOR BREAST, REF DYNJ905002B; c) SUCTION MEDI VAC, REF DYKM2033

Published August 28, 2024 · Recall initiated: March 22, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recall details

Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Distributor
Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
Lot
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
Risk classification
Class II
Area (FDA)
device
Country
United States

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