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Recall Observatory FDA recall evidence

Device product

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

Z-2701-2024

March 22, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 94356
Status
Ongoing
Classification
Class II
Quantity
26096 units
Official record key
device-enforcement:Z-2701-2024

Official wording

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

Code information: 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

Distribution pattern: Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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