Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119T; 2) NEUR
Summary
The FDA issued a Class II for Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANIOTO by MEDLINE INDUSTRIES, LP - Northfield. Reason: Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within t.
Details
Source
Device Recall
External ID
Z-0724-2025
Action Date
2025-01-01
Status
Ongoing
Category
device
Product Description
Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119T; 2) NEURO KIT, SKU CDS981327Q; 3) NEURO POSTERIOR SPINE PACK-LF, SKU DYNJ0311501I; 4) ACOUSTIC NEUROMA PACK-LF, SKU DYNJ37741D; 5) SCRIPPS SW NEURO PACK-LF, SKU DYNJ39836C; 6) SCRIPPS SW NEURO PACK-LF, SKU DYNJ39836D; 7) NEURO BUNDLE-LF, SKU DYNJ40095A; 8) NEURO BUNDLE-LF, SKU DYNJ40095B; 9) NEURO BUNDLE-LF, SKU DYNJ40095C; 10) NEURO BUNDLE-LF, SKU DYNJ40095D; 11) NEURO PACK-LF, SKU DYNJ42844D; 12) WMC VP SHUNT PACK-LF, SKU DYNJ50629J; 13) NEURO PACK, SKU DYNJ54255A; 14) NEURO CHRISTUS, SKU DYNJ61190A; 15) NEURO KIT, SKU DYNJ62854B; 16) NEURO KIT, SKU DYNJ62854C; 17) NEURO PACK NTX, SKU DYNJ66213D; 18) NEURO PACK, SKU DYNJ67628C; 19) BASIC NEURO CUSTOM, SKU DYNJ83387; 20) BASIC NEURO CUSTOM, SKU DYNJ83387A; 21) HALY NEURO PACK, SKU DYNJ87308; 22) FHWC NEURO, SKU DYNJ906131B; 23) CRANI, SKU DYNJ907865; 24) KIT NEURO LAFAYETTE, SKU DYNJ908615C; 25) GENERAL NEURO, SKU DYNJ909744
Lot/Code Info: UDI-DI: CDS780119T, 10888277762688 (each), 40888277762689 (case), Lot Numbers: 20EBU829; UDI-DI: CDS981327Q, 10195327080365 (each), 40195327080366 (case), Lot Numbers: 22FMH830 22FMF883; UDI-DI: DYNJ0311501I, 10889942265886 (each), 40889942265887 (case), Lot Numbers: 22DMF117; UDI-DI: DYNJ37741D, 10195327548940 (each), 40195327548941 (case), Lot Numbers: 24EMD032; UDI-DI: DYNJ39836C, 10193489510324 (each), 40193489510325 (case), Lot Numbers: 20JMB588 20GMD367 20EMB420 20CMC383 20CMA256; UDI-DI: DYNJ39836D, 10193489477177 (each), 40193489477178 (case), Lot Numbers: 22EMA431 22CMC948 22BMD597 22AMG597 21JMF846 21IMA074 21GMF465 21GMC844 21CME103 21CMD623 21BMC249; UDI-DI: DYNJ40095A, 10193489370690 (each), 40193489370691 (case), Lot Numbers: 21KME983 21JMB244 21JMB245 21HMA330 21EME688 21DME512 21CMA323 20LMD710 20HMB030; UDI-DI: DYNJ40095B, 10195327068325 (each), 40195327068326 (case), Lot Numbers: 22GMB406 22EMA845 22CME763; UDI-DI: DYNJ40095C, 10195327211028 (each), 40195327211029 (case), Lot Numbers: 22JMH236; UDI-DI: DYNJ40095D, 10195327281250 (each), 40195327281251 (case), Lot Numbers: 24HMC151 24GMA340 24DMK362 24CMH592 24BMF793 24AMF590 24AMD886 23LMB475 23KMD199 23IMF930 23HMG523 23HMB850 23GMI744 23GMH136 23FMD605 23EMC157 23CME914 23BMC902 22LME175; UDI-DI: DYNJ42844D, 10193489880564 (each), 40193489880565 (case), Lot Numbers: 22HBZ336; UDI-DI: DYNJ50629J, 10195327081324 (each), 40195327081325 (case), Lot Numbers: 22FBF021; UDI-DI: DYNJ54255A, 10889942765256 (each), 40889942765257 (case), Lot Numbers: 20LBO578 20HBM398 20FBW118 20EBG032 20DBF296; UDI-DI: DYNJ61190A, 10193489453355 (each), 40193489453356 (case), Lot Numbers: 23HBX568 23GBU378 23EBU255 23EBB228 23CBK006 23BBF587 22LBP590 22LBO797 22KBH699 22JBI769 22IBF404 22HMF895 22EMH841 22DMI740 22CMH488 22CME013 21JME676 21IMG224 21IMB620 21GMC966 21EMB917 21BMD698 21BMD492 21BMB573; UDI-DI: DYNJ62854B, 10193489324402 (each), 40193489324403 (case), Lot Numbers: 20HBA904; UDI-DI: DYNJ62854C, 10193489426984 (each), 40193489426985 (case), Lot Numbers: 24ABR077 23LBT405 23KBM929 23GBJ934 23FBA134 23DBP199 23BBI534 22LBQ392 22IBU624 22DBO531 22DBE837 21LBF713 21LBF714 21KBW798 21KBU432 21IBO584 21EBS026 21EBS045 21ABD769 21ABF202 20JBF504; UDI-DI: DYNJ66213D, 10195327345129 (each), 40195327345120 (case), Lot Numbers: 23IBN119 23HBT681 23GBA060 23FBF235 23DBR382 23CBI721; UDI-DI: DYNJ67628C, 10195327690342 (each), 40195327690343 (case), Lot Numbers: 24HMA885; UDI-DI: DYNJ83387, 10195327262945 (each), 40195327262946 (case), Lot Numbers: 22LBP363; UDI-DI: DYNJ83387A, 10195327365684 (each), 40195327365685 (case), Lot Numbers: 23IBS038 23GBF619 23EBP127 23DBI802; UDI-DI: DYNJ87308, 10198459025631 (each), 40198459025632 (case), Lot Numbers: 24GMB920; UDI-DI: DYNJ906131B, 10193489932386 (each), 40193489932387 (case), Lot Numbers: 22FBP752 22EBI045 22EBH247; UDI-DI: DYNJ907865, 10193489908725 (each), 40193489908726 (case), Lot Numbers: 22CMB545 22BMA169 21HMB808; UDI-DI: DYNJ908615C, 10198459082702 (each), 40198459082703 (case), Lot Numbers: 24HBS615; UDI-DI: DYNJ909744, 10195327465636 (each), 40195327465637 (case), Lot Numbers: 24ALA727 23JLA320
Quantity Affected: 12,889 kits
Reason for Recall
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Distribution
US Nationwide. Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-06
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 119 device recalls issued in the same week, part of 413 device-related FDA actions this month.
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0724-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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