Z-0723-2025 Class II Ongoing
FDA device recall Z-0723-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on November 6, 2024 and is designated Class II. 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 Sur… The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- January 1, 2025
- Initiation Date
- November 6, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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
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 Pattern
US Nationwide. Canada.
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