Medline medical procedure kits labeled as follows: a) MAJOR BREAST, REF DYNJ905004C; b) MINOR BREAST, REF DYNJ905002B; c) SUCTION MEDI VAC, REF DYKM2033
This recall is currently active, issued August 22, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- March 22, 2024
- Posted
- August 22, 2024
- Recall Number
- Z-2707-2024
- Quantity
- 3539 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Distribution
Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
Lot / Code Info
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
Root Cause
Under Investigation by firm
Action Taken
Medline Industries issued a Safety Alert to its consignees on 03/22/2024 via email and certified mail. The notice explained the problem with the device and requested that consignees follow the instructions for use. Distributors or those who further transferred the affected product were directed to notify their consignees.