Recall Z-0784-2025

MEDLINE INDUSTRIES, LP - Northfield · initiated November 21, 2024

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Medline custom medical procedure kits labeled as: 1) ENDOSCOPIC SKULL BASE, REF DYNJ58648B; 2) ENDOSCOPIC SKULL BASE, REF DYNJ58648C; 3) ENT ENDO SINUS WILMINGTON PACK, REF DYNJ66447; 4) ENDOSCOPIC SKULL BASE, REF DYNJ58648D; 5) ENDOSCOPIC SKULL BASE, REF DYNJ58648J.

Codes / lots: 1) REF DYNJ58648B, UDI/DI 10193489624182 (EA) 40193489624183 (CS), Lot Numbers: 19BDB193; 2) REF DYNJ58648C, UDI/DI 10193489688542 (EA) 40193489688543 (CS), Lot Numbers: 19EDD585, 19IDA770, 20AMA033, 20AMC750, 20EMB449; 3) REF DYNJ66447, UDI/DI 10193489367379 (EA) 40193489367370 (CS), Lot Numbers: 20KMC595, 21AMB129; 4) REF DYNJ58648D, UDI/DI 10195327212124 (EA) 40195327212125 (CS), Lot Numbers: 22KMD675, 23DMD129, 23HMG766, 23JMD938; 5) REF DYNJ58648J, UDI/DI 10193489356793 (EA) 40193489356794 (CS), Lot Numbers: 20EBN856, 20JBG508, 20JBK503, 20JBT975, 20KBQ270, 21ABK829, 21EBP637, 21EBP646, 21JBO555, 21KBC098, 21KBV126, 21LBP144.

Reason for recall

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.

FDA-determined cause: Nonconforming Material/Component

Action taken

Medline issued a MEDICAL DEVICE VOLUNTARY RECALL notice on 11/21/2024 to its consignees via US Mail and email. The notice explained the issue, potential risk to health, and requested that the affected product be quarantined. Once the response is received, Medline will provide labels to place on affected inventory, with instructions for the consignee to remove the affected component prior to using the kit.

Details

Recall number
Z-0784-2025
Initiated
November 21, 2024
Posted by FDA
December 30, 2024
Product code
NWU – Endoscope Introducer Kit
Quantity
1072 units
Distribution
Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0777-2025 Class IIMedline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… 11/21/2024Open, Classified
Z-0778-2025 Class IIMedline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… 11/21/2024Open, Classified
Z-0779-2025 Class IIMedline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS983470D; 2)…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… 11/21/2024Open, Classified
Z-0780-2025 Class IIMedline custom medical procedure kits labeled as: 1) UMC DR. BAKER SUPPLEMENT, REF…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… 11/21/2024Open, Classified
Z-0781-2025 Class IIMedline custom medical procedure kits labeled as: 1) NASAL PACK, REF DYNJ67789A.Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… 11/21/2024Open, Classified
Z-0782-2025 Class IISee DocManCustom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… 11/21/2024Open, Classified
Z-0783-2025 Class IIMedline custom medical procedure kits labeled as: 1) FREE FLAP BASIC SET-UP PK, REF…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… 11/21/2024Open, Classified
Z-0785-2025 Class IIMedline custom medical procedure kits labeled as: 1) PANENDOSCOPY-LF, REF DYNJ36728C; 2)…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… 11/21/2024Open, Classified
Z-0786-2025 Class IIMedline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, REF…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… 11/21/2024Open, Classified
Z-0787-2025 Class IIMedline custom medical procedure kits labeled as: 1) NEURO BASIN PACK-LF, REF…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… 11/21/2024Open, Classified
Z-0788-2025 Class IISee DocManCustom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… 11/21/2024Open, Classified
Z-0789-2025 Class IIMedline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, REF…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… 11/21/2024Open, Classified
Z-0790-2025 Class IISee DocManCustom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… 11/21/2024Open, Classified
Z-0791-2025 Class IIMedline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LFCustom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… 11/21/2024Open, Classified
Z-0792-2025 Class IIMedline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, REF DYNJ47568B…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… 11/21/2024Open, Classified
Z-0793-2025 Class IIMedline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF DYNJ0867145G…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… 11/21/2024Open, Classified
Z-0794-2025 Class IIMedline custom medical procedure kits labeled as: 1) CRANI, REF CDS780089V; 2)…Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical… 11/21/2024Open, Classified