medical Class II Updated 2025-01-08

MEDLINE INDUSTRIES, LP - Northfield recalls Medline custom medical procedure kits labeled as: 1) VP S

Recalled Product

Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS983470D; 2) 1/2X1/2 NEURO SPONGE PACK-LF, REF DYNJ0713177; 3) BURR HOLE SHUNT PACK, REF DYNJ56819D; 4) BURR HOLE SHUNT PACK, REF DYNJ56819F; 5) BURR HOLE SHUNT PACK, REF DYNJ56819G; 6) RO VP SHUNT PACK, REF PHS392834010D; 7) VP SHUNT, REF SYNJ10307A.

Hazard / Issue

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 1) REF CDS983470D, UDI/DI 10193489275339 (EA) 40193489275330(CS), Lot numbers: 20BDB519, 20EDA360, 20EDC040, 20GDA474, 20JDA107, 20KDA855, 21CDA110, 21EDA674, 21FDA748; 2) REF DYNJ0713177, UDI/DI 10889942085088 (EA) 40889942085089(CS), Lot numbers: 19AKC072, 19HKC645, 19KKA304, 20FKA539; 3) REF DYNJ56819D, UDI/DI 10193489254273 (EA) 40193489254274(CS), Lot numbers: 20AKA332, 20BKA860; 4) REF DYNJ56819F, UDI/DI 10193489353532 (EA) 40193489353533(CS), Lot numbers: 20EKB648, 20HKA426, 20JKA217, 20LKB026, 21FBT545, 21HBL828, 21KBY910, 21KBY914; 5) REF DYNJ56819G, UDI/DI 10195327073749 (EA) 40195327073740(CS), Lot numbers: 22CBJ951, 22HBJ403, 22LBQ584, 23BBH164, 23CBG816, 23FBM524; 6) REF PHS392834010D, UDI/DI 10193489222432 (EA) 40193489222433(CS), Lot numbers: 21LDA084; 7) REF SYNJ10307A, UDI/DI 10193489377026 (EA) 40193489377027(CS), Lot numbers: 20HBU444, 20HBW312, 21EBD895, 21FBE508, 21HBS523.
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