Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DYKE1872A, c) LOWER ENDO KIT, REF DYKE1921A, d) PACEMAKER, REF DYNJ901681D, e) UPPER ENDO KIT, REF DYKE1922A, f) VASCULAR, REF DYNJ905515D, g) VASCUALR, REF DYNJ902387K, h) VASCULAR III, REF DYNJS2035C
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-2701-2024
- Quantity
- 26096 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 DYNJ902752C, UDI/DI 40195327226993 (case), 10195327226992 (unit), Lot Numbers: 22IBA627, 22JBE922, 22JBP917, 22KBJ447, 23BBB611, 23CBC455, 23EBF908, 23FBV764, 23GBW761, 23IBR157; b) REF DYKE1872A, UDI/DI 40195327330027 (case), 10195327330026 (unit), Lot Numbers: 23CBB846, 23CBK197, 23DBK952, 23FBD020, 23FBG375, 23FBJ258, 23FBV848, 23HBA337, 23HBC022, 23IBA872, 23IBL364, 23JBB228, 23JBE437, 23JBE720, 23JBF969, 23JBV002, 23JBV507, 23KBG556, 23KBM618; c) REF DYKE1921A, UDI/DI 40195327488612 (case), 10195327488611 (unit), Lot Numbers: 23HBQ471, 23JBK197, 23LBD048; d) REF DYNJ901681D, UDI/DI 40193489308090 (case), 10193489308099 (unit), Lot Numbers: 22EBC373, 22EBD234, 22EBE775, 22EBF837, 22FBV877, 22GBT729, 23ABA707, 23BBI384, 23FBO404, 23GBO428, 23GBO470, 23JBH973; e) REF DYKE1922A, UDI/DI 40195327487943 (case), 10195327487942 (unit), Lot Numbers: 23IBK378, 23IBM326, 23JBP210, 23KBX462; f) REF DYNJ905515D, UDI/DI 40193489968041 (case), 10193489968040 (unit), Lot Numbers: 22FMB396, 22FMG767, 22IMB116, 22LMA842, 23AMI823, 23GMH322, 23IMC097; g) REF DYNJ902387K, UDI/DI 40195327505852 (case), 10195327505851 (unit), Lot Numbers: 23JBR461, 23KBT452; h) REF DYNJS2035C, UDI/DI 40193489214278 (case), 10193489214277 (unit), Lot Numbers: 22FDA441, 22GDA574, 22JDB543, 22LDB596, 23ADB285
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.