Medline brand recall: Endotoxin
Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F; 2) NASAL PACK, SKU DYNJ17493G; 3) FESS PACK-POB, SKU…
Why was Medline brand recalled?
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
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?
UDI-DI: CDS982901F, 10889942216970 (each), 40889942216971 (case), Lot Numbers: 23HBQ152; UDI-DI: DYNJ17493G, 10195327224424 (each), 40195327224425 (case), Lot Numbers: 23GBW775; UDI-DI: DYNJ33520A, 10884389851333 (each), 40884389851334 (case), Lot Numbers: 23HDB834; UDI-DI: DYNJ44845G, 10889942712311 (each), 40889942712312 (case), Lot Numbers: 23HBF195; UDI-DI: DYNJ48330B, 10195327113506 (each), 40195327113507 (case), Lot Numbers: 23HBO622; UDI-DI: DYNJ50572, 10889942008476 (each), 40889942008477 (case), Lot Numbers: 23GBR940; UDI-DI: DYNJ53573A, 10193489201635 (each), 40193489201636 (case), Lot Numbers: 23GBS356; UDI-DI: DYNJ58856A, 10193489750263 (each), 40193489750264 (case), Lot Numbers: 23HBO870; UDI-DI: DYNJ60111A, 10193489246995 (each), 40193489246996 (case), Lot Numbers: 21JMB783 21HMF433 21GMD178 21FMC923 20IMB575; UDI-DI: DYNJ60111B, 10195327527617 (each), 40195327527618 (case), Lot Numbers: 24HMC974 24GMA899 24FMB079 24EMC108 24DMD791 24CMG320; UDI-DI: DYNJ63052C, 10195327101312 (each), 40195327101313 (case), Lot Numbers: 22KME394 22KMA630 22JMD852 22GMG160 22EMG974 22DMF954 22CMC565; UDI-DI: DYNJ64256D, 10195327452773 (each), 40195327452774 (case), Lot Numbers: 23HBA766; UDI-DI: DYNJ64509B, 10195327323745 (each), 40195327323746 (case), Lot Numbers: 23HBC092; UDI-DI: DYNJ65644, 10193489283204 (each), 40193489283205 (case), Lot Numbers: 23HBA753; UDI-DI: DYNJ66749, 10193489375947 (each), 40193489375948 (case), Lot Numbers: 21ABT938 21ABO570 20JBS998 20HBM389; UDI-DI: DYNJ67423A, 10195327163402 (each), 40195327163403 (case), Lot Numbers: 24DLA092 24BLA235 23KLA058 23ILB043 23ILA503 23HLB296 23HLB011 23FLA068 23DLA463 23DLA185 23BLA617 22LLA582 22KLA652 22HLA029 22GLA884; UDI-DI: DYNJ67423B, 10195327686871 (each), 40195327686872 (case), Lot Numbers: 24GLB018 24FLA258 24ELA763 24DLA759; UDI-DI: DYNJ68102B, 10195327699369 (each), 40195327699360 (case), Lot Numbers: 24IBB348 24GBB791 24EBA114; UDI-DI: DYNJ80526B, 10195327211059 (each), 40195327211050 (case), Lot Numbers: 23HBF568; UDI-DI: DYNJ81280, 10195327102968 (each), 40195327102969 (case), Lot Numbers: 22HMF910; UDI-DI: DYNJ81420A, 10195327322601 (each), 40195327322602 (case), Lot Numbers: 24CBL416 23LBK136 23IBR308 23HBD265 23GBJ044 23FBK113 23EBN716 23BBQ143; UDI-DI: DYNJ81934, 10195327156817 (each), 40195327156818 (case), Lot Numbers: 23EBG024 23BBC727 22JBJ632 22HBH399; UDI-DI: DYNJ81934A, 10195327413019 (each), 40195327413010 (case), Lot Numbers: 24DBK564 24DBB486 24CBG998 24BBV700 24ABD320 23HBO084 23GBG012; UDI-DI: DYNJ83679A, 10195327459727 (each), 40195327459728 (case), Lot Numbers: 24HBP441 24GBF665 24BBO428 23LBS373 23JBD663 23IBN314; UDI-DI: DYNJ84270, 10195327349103 (each), 40195327349104 (case), Lot Numbers: 23GBC274; UDI-DI: DYNJ85422, 10195327499716 (each), 40195327499717 (case), Lot Numbers: 24FDA925 24ADB100; UDI-DI: DYNJ901299A, 10889942010349 (each), 40889942010340 (case), Lot Numbers: 21FBC250 20JBO761 20IBH831 20FBM501; UDI-DI: DYNJ901299B, 10193489923384 (each), 40193489923385 (case), Lot Numbers: 22FBU440 22OBC118 22OBC120 22ABA377 21JBJ197 21IBM868 21GBO441; UDI-DI: DYNJ905685D, 10198459024139 (each), 40198459024130 (case), Lot Numbers: 24IDB382; UDI-DI: DYNJ906474C, 10195327221355 (each), 40195327221356 (case), Lot Numbers: 24HDA228 24EDA811 24DDB542 23LDB493 23GDA771 23DDA732 22IDB976; UDI-DI: DYNJ906839A, 10195327092528 (each), 40195327092529 (case), Lot Numbers: 22JMB394; UDI-DI: DYNJ908545A, 10195327384166 (each), 40195327384167 (case), Lot Numbers: 23JBV681; UDI-DI: DYNJ908545B, 10195327593124 (each), 40195327593125 (case), Lot Numbers: 24HBI988 24FBS776 24FBA297 24ABT058; UDI-DI: DYNJ909128A, 10195327326739 (each), 40195327326730 (case), Lot Numbers: 23EBD903 23DBD851; UDI-DI: DYNJ909128C, 10195327458416 (each), 40195327458417 (case), Lot Numbers: 23JBO251 23HBI313; UDI-DI: DYNJ909128D, 10195327516321 (each), 40195327516322 (case), Lot Numbers: 24EBC023 24CBK211 24BBM816 24ABR742 23LBQ695 23LBM416; UDI-DI: DYNJ909128F, 10198459055256 (each), 40198459055257 (case), Lot Numbers: 24HBV054 24GBN495; UDI-DI: DYNJ909370, 10195327319038 (each), 40195327319039 (case), Lot Numbers: 24BMA818 24AMG256 23LMF420 23LMB722 23LMA458 23CME287;
- Product
- Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F; 2) NASAL PACK, SKU DYNJ17493G; 3) FESS PACK-POB, SKU…
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 6467 kits
- Distribution
- US Nationwide. Canada.
- Recall date
- January 1, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)