Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Medline product number/SKU DYNJ909020B, UDI/DI 10198459159213 (each) 40198459159214 (case), Lot number 26AMF311; Medline product number/SKU DYNJ909020B, UDI/DI 10198459159213 (each) 40198459159214 (case), Lot number 25JMD500; Medline product number/SKU DYNJ909020B, UDI/DI 10198459159213 (each) 40198459159214 (case), Lot number 25DMJ849; Medline product number/SKU DYNJ909020B, UDI/DI 10198459159213 (each) 40198459159214 (case), Lot number 25CMD823; Medline product number/SKU DYNJ909020B, UDI/DI 10198459159213 (each) 40198459159214 (case), Lot number 25BMG250; Medline product number/SKU DYNJ909020B, UDI/DI 10198459159213 (each) 40198459159214 (case), Lot number 24LMG633; Medline product number/SKU DYNJ909020A, UDI/DI 10195327665760 (each) 40195327665761 (case), Lot number 24KMB736; Medline product number/SKU DYNJ909020A, UDI/DI 10195327665760 (each) 40195327665761 (case), Lot number 24JMD634; Medline product number/SKU DYNJ909020A, UDI/DI 10195327665760 (each) 40195327665761 (case), Lot number 24IMD605; Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 24HBT243; Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 24HBD143; Medline product number/SKU DYNJ909020A, UDI/DI 10195327665760 (each) 40195327665761 (case), Lot number 24GMG103; Medline product number/SKU DYNJ909020A, UDI/DI 10195327665760 (each) 40195327665761 (case), Lot number 24DMI379; Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 24CBJ928; Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 24BME929; Medline product number/SKU DYNJ65706, UDI/DI 10193489284904 (each) 40193489284905 (case), Lot number 24AMF210; Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 24AMD338; Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 23LME666; Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 23LMB230; Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 23KMF895; Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 23KMD188; Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 23HMH838; Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 23HBG421; Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 23FBD203; Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 23EBL260; Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 23CMB011; Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 23CBU833; Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 22BBV592; Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 22BBJ850; Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 22ABL217; Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 21LBM269; Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 21HBC597; Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 21GBE864; Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 21FBJ082.
✅ What Should You Do?
1Contact your healthcare provider immediately to discuss this recall.
2Stop using the device if it is safe to do so, and contact your provider.
3Follow the manufacturer's remedy instructions provided in the recall notice.
4Report device problems to FDA MedWatch or call 1-800-FDA-1088.