Z-0787-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 8, 2025
- Initiation Date
- November 21, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3684 units
Product Description
Medline custom medical procedure kits labeled as: 1) NEURO BASIN PACK-LF, REF DYNJ39461J; 2) NEURO BASIN KIT, REF DYNJ80200B.
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 Pattern
Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
Code Information
1) REF DYNJ39461J, UDI/DI 10195327112721 (EA) 40195327112722 (CS), Lot Numbers: 22BBZ954, 22FBB472, 22GBS127, 22HBJ021, 22IBN757, 22LBN387, 22LBP618, 23BBL804, 23FBL965, 23HBG346, 23IBV491, 23JBW568, 24ABJ924, 24CBG585, 24DBM211, 24FBN899, 24FBQ913, 24HBL252, 24HBV561; 2) REF DYNJ80200B, UDI/DI 10195327213978 (EA) 40195327213979 (CS), Lot Numbers: 22HBG124, 22IBJ978, 22JBL067, 22LBQ534, 23ABM279, 23BBR168, 23DBB055, 23EBV555, 23GBB476, 23IBF093, 23KBT109, 24ABA171, 24CBB183, 24DBM493, 24GBB326, 24HBB911.