Medline custom medical procedure kits labeled as: 1) recall: Endotoxin
Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, REF DYNJ0660040R; 2) FREE FLAP PACK-LF, REF DYNJ42833A; 3) FREE FLAP…
Why was Medline custom medical procedure kits labeled as: 1) recalled?
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, REF DYNJ0660040R; 2) FREE FLAP PACK-LF, REF DYNJ42833A; 3) FREE FLAP…
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 3903 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
- Recall date
- January 8, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)