Class 2 Device Recall

• Date Initiated by Firm: November 06, 2024
• Date Posted: December 20, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0723-2025
• Recall Event ID: 95806
• Product Classification: General surgery tray - Product Code LRO
• Product: Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY, SKU CDS982719X; 2) MVFF/FIBU #54-RF, SKU DYNJ21927Q; 3) MVFF/FIBU #54-RF, SKU DYNJ21927S; 3) NEURO PEDIATRIC, SKU DYNJ61607A; 4) CRANIOTOMY PACK, SKU DYNJ66419C; 5) LYMPHATIC BYPASS PACK, SKU DYNJ69907; 6) LYMPHATIC BYPASS PACK, SKU DYNJ69907A; 7) HEAD AND NECK PACK - 51597, SKU DYNJ81934B; 8) MAJOR CRANIOTOMY PACK, SKU DYNJ82007A; 9) SPINE PACK, SKU DYNJ82011A; 10) CRANIOTOMY MERCY STK 256, SKU DYNJ84068; 11) WMC UNIVERSAL NEURO PACK, SKU DYNJ84496A; 12) SPINE PACK LF, SKU DYNJ85830; 13) AHT SPINE PACK, SKU DYNJ903566D; 14) LAMINECTOMY SPINAL FUSION PACK, SKU DYNJ909364A; 15) DIEP, SKU DYNJ909472; 16) AMBULATORY SINUS, SKU DYNJ910292; 17) AMBULATORY SINUS, SKU DYNJ910292A
• Code Information: UDI-DI: CDS982719X, 10198459064531 (each), 40198459064532 (case), Lot Numbers: 24IBE288; UDI-DI: DYNJ21927Q, 10889942885534 (each), 40889942885535 (case), Lot Numbers: 21LBB957 21KBA966 21IBN569 21GBO771 20KBB297 20JBB045 20IBI973 20HBU423 20HBC730 20EBU633; UDI-DI: DYNJ21927S, 10195327576233 (each), 40195327576234 (case), Lot Numbers: 24GBQ357 24GBK331 24FBF951 24CBV435 24BBN342 24ABW268; UDI-DI: DYNJ61607A, 10193489665734 (each), 40193489665735 (case), Lot Numbers: 22FLB055 22FLA458; UDI-DI: DYNJ66419C, 10198459059353 (each), 40198459059354 (case), Lot Numbers: 24IBG439; UDI-DI: DYNJ69907, 10193489995558 (each), 40193489995559 (case), Lot Numbers: 22EMA026; UDI-DI: DYNJ69907A, 10195327163976 (each), 40195327163977 (case), Lot Numbers: 22FMB386; UDI-DI: DYNJ81934B, 10198459122910 (each), 40198459122911 (case), Lot Numbers: 24IBG522; UDI-DI: DYNJ82007A, 10195327635466 (each), 40195327635467 (case), Lot Numbers: 24IME319 24HMI978 24HMI081 24CMA496; UDI-DI: DYNJ82011A, 10195327635480 (each), 40195327635481 (case), Lot Numbers: 24HMI979 24GMJ808 24GMB190 24FMD601 24EMD223 24BMJ118; UDI-DI: DYNJ84068, 10195327332143 (each), 40195327332144 (case), Lot Numbers: 23HLA314; UDI-DI: DYNJ84496A, 10198459011245 (each), 40198459011246 (case), Lot Numbers: 24HBF172 24FBN697; UDI-DI: DYNJ85830, 10195327556471 (each), 40195327556472 (case), Lot Numbers: 24IBG585 24DBO636 24BBK513; UDI-DI: DYNJ903566D, 10195327560829 (each), 40195327560820 (case), Lot Numbers: 24BBO346 24BBK920 24ABO451 24ABO420; UDI-DI: DYNJ909364A, 10195327660420 (each), 40195327660421 (case), Lot Numbers: 24IMD666 24IMB155 24GMA069 24EMH357; UDI-DI: DYNJ909472, 10195327368821 (each), 40195327368822 (case), Lot Numbers: 24IMD560 24GMI069 23LMG055 23KMD713 23GME971 23GMA619; UDI-DI: DYNJ910292, 10195327618681 (each), 40195327618682 (case), Lot Numbers: 24HBI255 24HBF816 24GBR460 24FBL017; UDI-DI: DYNJ910292A, 10198459111723 (each), 40198459111724 (case), Lot Numbers: 24IBK954
• FEI Number: 1417592
• Recalling Firm/ Manufacturer: MEDLINE INDUSTRIES, LP - Northfield; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Karin Johnson; 866-359-1704
• Manufacturer 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: 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.
• Distribution: US Nationwide. Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.