Skip to content
RecallWatchMedical Device Safety
Class IIOngoingZ-0779-2025

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

MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesReported Jan 8, 2025 · 1 year ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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.

Lot / code information

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

What the firm is doing

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.

DistributionShow details

Worldwide distribution - US Nationwide and the countries of UAE, and Canada.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

More Class II recalls