| Class 2 Device Recall Medline |  |
Date Initiated by Firm | April 17, 2024 |
Date Posted | May 31, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1936-2024 |
Recall Event ID |
94477 |
Product Classification |
Syringe, piston - Product Code FMF
|
Product | 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 Information |
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
|
Recalling Firm/ Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield 3 Lakes Dr Northfield IL 60093-2753
|
For Additional Information Contact | Karin Johnson 886-359-1704 |
Manufacturer 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. |
FDA Determined Cause 2 | Under Investigation by firm |
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. |
Quantity in Commerce | 2,348,430 syringes |
Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Panama. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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