Device recalls

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: DY…

MEDLINE INDUSTRIES, LP - Northfield · 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…

Open, ClassifiedUnder Investigation by firmZ-1936-2024
Open FDA's page for this record
Cfres ID
207284
Product res number
Z-1936-2024
Event date initiated
2024-04-17
Event date posted
2024-05-31
Recall status
Open, Classified
Res event number
94477
Product code
FMF
Firm FEI number
1417592
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Address 1
3 Lakes Dr
City
Northfield
State
IL
Postal code
60093-2753
Additional info contact
Karin Johnson 886-359-1704
Root cause description
Under Investigation by firm
Product quantity
2,348,430 syringes
Distribution pattern
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Product description

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

Code info

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

Reason for recall

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.

Action

Medline Industries, LP issued a recall notice to its consignees on 04/17/2024 via USPS, First Class mail. The notice explained the issue, potential risk to the user, and requested the consignee destroy all affected product. If the product was further distributed, the party distributing the affected product was directed to notify their customers.

Harmonized identifiers (openFDA)
Device name
Syringe, Piston
Medical specialty description
General Hospital
Regulation number
880.5860
Device class
2
K number
K091377, K811167, K801311, K121124, K061275, K930321, K122023, K870192, K182279, K913235, K853450, K212207, K960882, K884921, K851089, K850958, K011176, K950666, K881980, K051720, K883744, K883094, K021993, K761158, K070264, K010890, K182274, K881791, K062365, K820294, K222744, K964597, K930791, K910520, K941020, K843473, K893862, K010708, K911440, K141762 +712 more
Registration number
3004111573, 3006948745, 3005853033, 9681413, 3012944064, 3024088964, 3023174629, 1647137, 8031007, 3006788678, 3014315664, 1410248, 3014747754, 3014615644, 3014680149, 1450662, 3027500452, 9612152, 9611024, 3008650117, 3005941719, 3004054016, 3012461127, 3007084575, 3011504993, 1066491, 3025432964, 3009746061, 3008808123, 3016245399, 3013517171, 3006498370, 3005405146, 3030412764, 3007007790, 3043226252, 3019807891, 3003152976, 3011230048, 1825034 +511 more
FEI number
1000268645, 3004111573, 3006948745, 3005853033, 3003056094, 3012944064, 3024088964, 3023174629, 1000306431, 3006788678, 3002808169, 3003857949, 3014315664, 1410248, 1000112877, 3014747754, 3014615644, 3014680149, 1450662, 3027500452, 3003640911, 3008650117, 3004054016, 3012461127, 3007084575, 3011504993, 3002808374, 3025432964, 3009746061, 3008808123, 3016245399, 3013517171, 3006498370, 3005405146, 3030412764, 3007007790, 3043226252, 3019807891, 3003152976, 3011230048 +511 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.