Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, REF DYNJ0660040R; 2) FREE FLAP PACK-
Summary
The FDA issued a Class II for Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-L by MEDLINE INDUSTRIES, LP - Northfield. Reason: Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endot.
Details
Source
Device Recall
External ID
Z-0786-2025
Action Date
2025-01-08
Status
Ongoing
Category
device
Product Description
Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, REF DYNJ0660040R; 2) FREE FLAP PACK-LF, REF DYNJ42833A; 3) FREE FLAP PACK-LF, REF DYNJ42833B; 4) TYMPANOPLASTY PACK, REF DYNJ50692C; 5) MAJOR CRANIOTOMY SAFETY, REF DYNJ54736B; 6) FREE FLAP CUSTOM PACK A, REF DYNJ82735; 7) NSR-SMR, REF DYNJ903144C; 8) KIT FACIAL MINORPLASTICS MOSES, REF DYNJ905365A; 9) SEPTOPLASTY, REF DYNJ906474; 10) SEPTOPLASTY, REF DYNJ906474A; 11) FREE FLAP, REF DYNJ907802; 12) MINOR DIEP, REF DYNJ907863; 13) MAIN FLAP, REF DYNJ908264.
Lot/Code Info: 1) REF DYNJ0660040R, UDI/DI 10889942220083 (EA) 40889942220084 (CS), Lot Numbers: 19BKB772, 19DKB804, 19FKB661, 19GKD118, 19IKA148, 19KKB086, 20AKB057, 20BKB114, 20FKB215, 20JKA546, 20LMA968, 20LMF795, 21DMA309, 21DMF310, 21FMA264, 21GMB043, 21HMD757, 21JMC608, 21KMH631, 22CMB438; 2) REF DYNJ42833A, UDI/DI 10888277503991 (EA) 40888277503992 (CS), Lot Numbers: 19ABS779, 19EBZ888, 19FBJ253, 19FBO513, 19FBX305, 19GBF427, 19LBY431, 20CBD972, 20DBV565, 20HBL275, 20LBA473, 20LBG895, 21CBI208; 3) REF DYNJ42833B, UDI/DI 10193489880335 (EA) 40193489880336 (CS), Lot Numbers: 21GBJ447, 21GBJ449, 21HBM834, 21HBR207, 22CBT921, 22DBM124, 22GBD852, 22HBF050, 22HBJ420, 22IBJ529, 22KBR876, 23BBA545, 23CBD715, 23CBQ582, 23DBH453, 23HBE012, 23HBR165, 23IBK906, 23KBP817, 24BBA648, 24DBD590, 24FBI859, 24GBU033, 24IBG868, 24JBI576; 4) REF DYNJ50692C, UDI/DI 10193489752199 (EA) 40193489752190 (CS), Lot Numbers: 19KDA566, 20BDC412, 20CDA575, 20GMD317, 21DMA002; 5) REF DYNJ54736B, UDI/DI 10889942925483 (EA) 40889942925484 (CS), Lot Numbers: 19ABB603, 19ABV222, 19CBN379, 19DBS122, 19EBZ894, 19FBQ049; 6) REF DYNJ82735, UDI/DI 10195327207540 (EA) 40195327207541 (CS), Lot Numbers: 22KMF252, 23EMG596, 23FMA429, 23IMA461, 23JMC236, 24BMC071; 7) REF DYNJ903144C, UDI/DI 10193489677881 (EA) 40193489677882 (CS), Lot Numbers: 19JBK003, 19SBD201, 20ABZ780, 20FBK295, 20GBR819, 20IBH005, 20LBK729, 20LBL461, 20LBO417, 20LBU129, 22AMA090, 22AMC790, 22BMF138, 22EMH876; 8) REF DYNJ905365A, UDI/DI 10193489759037 (EA) 40193489759038 (CS), Lot Numbers: 19IBR377, 20CBO773, 20GBI734, 20GBJ843, 20HBC012, 20IBQ906, 20JBO730, 21CBZ725, 21DBU031, 21GBF999, 21IBC232, 21VBB589; 9) REF DYNJ906474, UDI/DI 10193489750492 (EA) 40193489750493 (CS), Lot Numbers: 20ADB316, 20BDC489; 10) REF DYNJ906474A, UDI/DI 10193489344721 (EA) 40193489344722 (CS), Lot Numbers: 20EDC407, 20FDB425, 20HDA265, 20KDA931, 20KDC466, 21BDA054, 21EDA134, 21FDB465, 21GDB063, 21HDB526, 21IDA248; 11) REF DYNJ907802, UDI/DI 10193489890006 (EA) 40193489890007 (CS), Lot Numbers: 21GBI826, 22IBH914; 12) REF DYNJ907863, UDI/DI 10193489913187 (EA) 40193489913188 (CS), Lot Numbers: 21GBJ056, 21JBZ373, 21KBX700, 21LBV116; 13) REF DYNJ908264, UDI/DI 10195327020118 (EA) 40195327020119 (CS), Lot Numbers: 21LBU103.
Quantity Affected: 3903 units
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.
Distribution
Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-21
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 134 device recalls issued in the same week, part of 413 device-related FDA actions this month.
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0786-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29