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Medline brand, medical procedure convenience kits, labeled… recallZ-0724-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Nov 6, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Nonconforming Material/Component

What the company is doing

An IMMEDIATE ACTION REQUIRED MEDICAL DEVICE RECALL notification letter dated 11/7/24 was sent to customers. REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. Quarantine all affected product immediately. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. 3.Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. The login for completing the response form is: Website link: https://recalls.medline.comRecall Reference #: R-24-209-FGX1 Recall Code: Recall Code 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].

Recall details

Recall number
Z-0724-2025
Status
Open, Classified
Initiated by the company
Nov 6, 2024
Posted by the FDA
Dec 20, 2024
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
12,889 kits
Product code
OJG
Distribution
US Nationwide. Canada.

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

Code information (models, lots, serial numbers)

Show the full code information (3k characters)

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

Devices named in this recall

25 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 95806).

Sources and updates

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