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.
This recall is currently active, issued December 30, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- November 21, 2024
- Posted
- December 30, 2024
- Recall Number
- Z-0779-2025
- Quantity
- 1402 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Distribution
Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
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.
Root Cause
Nonconforming Material/Component
Action Taken
Medline issued a MEDICAL DEVICE VOLUNTARY RECALL notice on 11/21/2024 to its consignees via US Mail and email. The notice explained the issue, potential risk to health, and requested that the affected product be quarantined. Once the response is received, Medline will provide labels to place on affected inventory, with instructions for the consignee to remove the affected component prior to using the kit.