Medline custom medical procedure kits labeled as: 1) recall: Endotoxin
Medline custom medical procedure kits labeled as: 1) FREE FLAP BASIC SET-UP PK, REF DYNJ0991320J; 2) MVFF/FIBU #54-RF, REF DYNJ21927R; 3) FUNCTIONAL…
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 DYNJ0991320J, UDI/DI 10193489686661 (EA) 40193489686662 (CS), Lot Numbers: 19EKB321, 19GKD099, 19JKA065, 19LKB378, 20DKA223, 20EKA239, 20FKB859, 20GKA150, 20HKB438, 21ALA327; 2) REF DYNJ21927R, UDI/DI 10195327104733 (EA) 40195327104734 (CS), Lot Numbers: 23JBK732; 3) REF DYNJ40406A, UDI/DI 10889942215904 (EA) 40889942215905 (CS), Lot Numbers: 23HBD879; 4) REF DYNJ51818F, UDI/DI 10889942741601 (EA) 40889942741602 (CS), Lot Numbers: 19BBA689, 19CBD918; 5) REF DYNJ58648F, UDI/DI 10193489884449 (EA) 40193489884440 (CS), Lot Numbers: 21EMF317; 6) REF DYNJ66867A, UDI/DI 10193489986235 (EA) 40193489986236 (CS), Lot Numbers: 22ABE990, 22FBV019, 22KBK097, 22NBE822, 23DBG870, 23EBR848, 23FBA588, 23HBX771, 23IBW237, 23KBC127, 23KBT141; 7) REF DYNJ905366A, UDI/DI 10193489759372 (EA) 40193489759373 (CS), Lot Numbers: 19LBL885, 20BBJ487, 20CBF683, 20FBC462, 20HBN061, 21CBU514, 21DBO189, 21EBI475, 21EBN240, 21FBT699, 21FBT700, 21FBT702, 21KBN245; 8) REF DYNJ905634B, UDI/DI 10193489633924 (EA) 40193489633925 (CS), Lot Numbers: 19EBD435, 19EBL594, 19FBG295, 19GBR466, 19GBS384, 20FBS328, 21EBM629, 21FBP379, 21FBT340, 22GMH714, 23CMF811, 23DMA128, 23JMD524, 24AMJ344, 24BME042, 24DMB281, 24EMI831, 24FMC477; 9) REF DYNJ907817, UDI/DI 10193489887167 (EA) 40193489887168 (CS), Lot Numbers: 21EBC333; 10) REF DYNJ908165, UDI/DI 10193489992014 (EA) 40193489992015 (CS), Lot Numbers: 22CLA236, 22CLA782, 22FLA058, 22JBI497, 23BBD054, 23BBF440, 23BBG445, 23BBL712, 23FBA102, 23IBO315, 23KBH043, 23KBH076, 23LBG978; 11) REF DYNJ910072, UDI/DI 10195327567538 (EA) 40195327567539 (CS), Lot Numbers: 24CBL710; 12) REF DYNJ910120A, UDI/DI 10195327689872 (EA) 40195327689873 (CS), Lot Numbers: 24HMK254.
- Product
- Medline custom medical procedure kits labeled as: 1) FREE FLAP BASIC SET-UP PK, REF DYNJ0991320J; 2) MVFF/FIBU #54-RF, REF DYNJ21927R; 3) FUNCTIONAL…
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 943 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)