MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2024 - (Recall #: Z-1936-2024)

Syringes labeled as: a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881, 2. DYNJSYRPPC10; b) SYRINGE 20ML BLUE L/L LOW PR, Item Number: DYNJSYRPP20B; c) SYRINGE 20ML RED L/L LOW PRESS, Item Number: DYNJSYRPP20R; d) SYRINGE 10ML RED L/L LOW PR, Item Number: DYNJSYRPP10R; e) SYRINGE 10ML GREEN L/L LOW PR, Item Number: DYNJSYRPP10G; f) SYRINGE 10ML WHITE L/L LOW PR, Item Number: DYNJSYRPP10W; g) SYRINGE CNTRL 10ML RED L/L LP, Item Number: DYNJSYCPP10R; h) SYRINGE 5ML YELLOW L/L LOW PR, Item Number: DYNJSYRPP5Y; i) SYRINGE CNTRL 10ML YEL L/L LP, Item Number: DYNJSYCPP10Y; j) SYRINGE 3ML YELLOW L/L LOW PR, Item Number: DYNJSYRPP3Y; k) SYRINGE 5ML WHITE L/L LOW PR, Item Number: DYNJSYRPP5W; l) SYRINGE,CONTROL,LL,FINGER GRIPS,10ML, Item Number: DYNJPOLYCON1

Class II

These syringes were identified to be affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and other quality issues have been identified that may pose a risk to patient health.

a) Item Numbers: 1. DNSC91881, GTIN 10884389730225, Lot Numbers: 23KDA810, 23KDA809, 23KDA808, 23JDB372, 23JDB371, 23JDB370, 23FDB723, 23FDB722, 23FDB721, 23EDC604, 23EDC601, 23EDC598, 23DDA082, 23CDA063, 22LDB994, 22JDB444, 22JDB317, 22GDA044, 22CDB364, 22CDB363, 22BDB197, 22BDB107, 22ADC307, 22ADC306, 21KDB939, 21KDB938, 21KDB937, 21KDB854, 21KDB195, 21KDA579, 21KDA578, 21JDC617, 21JDC189, 21JDC188, 21JDC187, 21IDC072, 21IDC071, 21IDC070, 21GDA290, 21FDA195, 21FDA194, 21FDA193, 21EDB429, 21EDB114, 21DDC271, 21DDC270, 21DDC269, 20593, 21DDA598, 21DDA597, 21DDA596, 21DDA121, 21CDA858, 21CDA830, 21CDA816, 21BDA571, 21BDA566, 21BDA236, 21ADA763, 21ADA762, 21ADA761, 20KDB349, 20KDB348, 20KDB345, 20HDC716, 20HDC715, 20HDC714, 20FDB669, 20FDA588, 20FDA587, 20FDA578, 20DDB051, 20DDB050, 20DDB040, 20CDA310, 20BDC437, 20BDC430, 20BDB460, 19LDC885, 19JDB712, 19JDB707, 19JDB701, 19JDA632, 19IDB925, 19IDB160, 19IDB010, 19IDA604, 19HDA821, 8501-4, 19FDA536, 19EDD493, 19EDB908, 19EDB897, 19EDB002, 19DDB541, 19CDB785, 19CDA598, 19CDA587, 19BDB418, 19BDA447, 19ADB979, 19ADB382, 19ADA155; 2. DYNJSYRPPC10, GTIN 40884389854175, Lot Numbers: 21EBO376, 21EBO373, 21EBE760, 21EBE676, 19EBS670, 19PBB067, 19CBF350, 19ABI078, 21GBA704; b) Item Number: DYNJSYRPP20B, GTIN 40193489510615, Lot Numbers: 19DBF219; c) Item Number: DYNJSYRPP20R, GTIN 40193489510646, Lot Numbers: 19VBF198, 22KBI924, 22KBH332, 22JBN941, 22JBE021, 22DBO577, 22BBH657; d) Item Number: DYNJSYRPP10R, GTIN 40193489510677, Lot Numbers: 23JBQ600, 23HBB479, 23GBR483, 23EBC497, 23DBH387, 19VBF197, 22JBF882, 22OBC539, 22OBC538, 22OBA224, 22CBV052; e) Item Number: DYNJSYRPP10G, GTIN 40193489510684, Lot Numbers: 23HBW354; f) Item Number: DYNJSYRPP10W, GTIN 40193489510691, Lot Numbers: 24ABB058, 24ABB057, 24ABB056, 24ABB055, 24ABB054, 23KBL638, 23JBV978, 23FBP607, 23FBN611, 23FBD501, 23FBD500, 23EBW297, 23BBK362, 23BBG403, 23BBF237, 22JBJ540, 22JBE187, 22JBE023, 22OBD675, 22OBD674, 22OBA198, 22BBH572, 22ABZ717, 21LBD201, 21KBJ994; g) Item Number: DYNJSYCPP10R, GTIN 40193489510776, Lot Numbers: 22JBR164; h) Item Number: DYNJSYRPP5Y, GTIN 40193489511209, Lot Numbers: 23HBW356, 19VBF199; i) Item Number: DYNJSYCPP10Y, GTIN 40193489511216, Lot Numbers: 22JBR165; j) Item Number: DYNJSYRPP3Y, GTIN 40193489511377, Lot Numbers: 23HBW355; k) Item Number: DYNJSYRPP5W, GTIN 40193489510769, Lot Numbers: 23CBN165, 23CBA105, 23BBM437, 23BBE585, 23BBE124, 22LBN160, 22KBI921, 22KBH212, 22EBK611, 22OBM559, 21KBV178, 21KBP743, 21KBN796; l) Item Number: DYNJPOLYCON1,GTIN 10889942000500, Lot Numbers: 63719060006, 63719060007, 63719060007, 63719060007, 63719060007, 63719060007, 63719060007, 63719060007, 63719070006, 63719080005, 63719080005, 63719080005, 63719100007, 63719100007, 63719100007, 63719120006, 63721050003, 63721050003, 63721050003, 63721050003, 63721050003, 63721050003, 63721050003, 63721060003, 63721070005, 63721070008, 63721070008, 63721090007, 63721110005, 63721120005, 63722020001, 63722030005, 63722030005, 63722030005, 63722030005, 63722030005, 63722050004, 63722040008, 63722090008, 63722100001, 63722100005, 63722100006, 63722110002, 63722120005, 63722120006, 63722120006, 63723020005, 63724010001, 63724010001

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

Voluntary: Firm initiated