MEDLINE INDUSTRIES, LP - Northfield: Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F; 2) NASAL PACK, SKU DYNJ17493G; 3) FESS PACK-POB, SKU DYNJ33520A; 4)

Hazard

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

Details from the source

Reason for recall: 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 Distribution: US Nationwide. Canada. Quantity: 6467 kits Lot/code info: 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

UPC codes

10889942216970, 40889942216971, 10195327224424, 40195327224425, 10884389851333, 40884389851334, 10889942712311, 40889942712312, 10195327113506, 40195327113507, 10889942008476, 40889942008477, 10193489201635, 40193489201636, 10193489750263, 40193489750264, 10193489246995, 40193489246996, 10195327527617, 40195327527618, 10195327101312, 40195327101313, 10195327452773, 40195327452774, 10195327323745, 40195327323746, 10193489283204, 40193489283205, 10193489375947, 40193489375948, 10195327163402, 40195327163403, 10195327686871, 40195327686872, 10195327699369, 40195327699360, 10195327211059, 40195327211050, 10195327102968, 40195327102969

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.