Recall Z-0724-2025
MEDLINE INDUSTRIES, LP - Northfield · initiated November 6, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: 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…
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
FDA-determined cause: Nonconforming Material/Component
Action taken
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 recalls@medline.com.
Details
- Recall number
- Z-0724-2025
- Initiated
- November 6, 2024
- Posted by FDA
- December 20, 2024
- Product code
- OJG – Neurological Tray
- Quantity
- 12,889 kits
- Distribution
- US Nationwide. Canada.
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0717-2025 Class II | MAJOR NEURO PACK-LF Convenience kit, SKU DYNJ0578916X. Convenience kits used for various…Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain… | 11/06/2024Open, Classified |
| Z-0718-2025 Class II | FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for various…Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain… | 11/06/2024Open, Classified |
| Z-0719-2025 Class II | DIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various procedures.Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain… | 11/06/2024Open, Classified |
| Z-0720-2025 Class II | Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU…Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain… | 11/06/2024Open, Classified |
| Z-0721-2025 Class II | Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU…Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain… | 11/06/2024Open, Classified |
| Z-0722-2025 Class II | SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various…Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain… | 11/06/2024Open, Classified |
| Z-0723-2025 Class II | Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY, SKU…Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain… | 11/06/2024Open, Classified |
| Z-0725-2025 Class II | KIT,SPINE LH Convenience kit, SKU DYNJ906448A.Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain… | 11/06/2024Open, Classified |
| Z-0726-2025 Class II | Medline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOMY CDS-LF…Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain… | 11/06/2024Open, Classified |