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U.S. Department of Health and Human Services

Class 1 Device Recall MEDLINE

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  Class 1 Device Recall MEDLINE see related information
Date Initiated by Firm November 15, 2023
Date Posted February 25, 2024
Recall Status1 Open3, Classified
Recall Number Z-1102-2024
Recall Event ID 93800
Product Classification laparoscopy kit - Product Code FDE
Product MEDLINE Kits, trays, and packs labeled as follows:
a) ASC GENERAL MINOR CDS, REF CDS983673G;
b) ASC GENERAL MINOR CDS, REF CDS983673I;
c) C NURSE BAG KIT, REF DYKM1425;
d) DAILY DRIVELINE MGMT KIT w/PER, REF DT18700;
e) GASTRIC CULTURE PACK, REF DYNJ53966A;
f) GASTRIC CULTURE PACK, REF DYNJ53966AH;
g) HERNIA, REF CDS982034R;
h) HERNIA, REF CDS982034S;
i) HERNIA PACK, REF DYNJ39331B;
j) LAP APPY PACK, REF DYNJ37709J;
k) LAP CHOLE CDS, REF CDS983912V;
l) LAP CHOLE CDS, REF CDS983912W;
m) LAP CHOLE CDS, REF CDS983912X;
n) LAP CHOLE CDS, REF CDS983912Y;
o) LAPAROSCOPY PACK, REF DYNJ41417J;
p) LAPAROTOMY CDS-LF, REF CDS860091A;
q) LOWER EXTREMITY, REF DYNJ46222M;
r) MAJOR PACK, REF DYNJ80578A;
s) MINOR PACK, REF DYNJ67217D;
t) N L MINOR CDS, REF CDS982518O;
u) N L MINOR CDS, REF CDS982518P;
v) NON STERILE I&D KIT, REF DYKM1438;
w) PACK,GU MINOR, REF DYNJ906885B;
x) PLASTICS SUTURE TRAY, REF SUT13535;
y) RESPIRATORY KIT, REF DYKM1404;
z) TRACH CARE TRAY, REF DYNDJ1057A;
Code Information a) REF CDS983673G, UDI/DI 40193489951746 (case), 10193489951745 (unit), Lot Numbers: 22EDA378, 22EDB208; b) REF CDS983673I, UDI/DI 40195327147335 (case), 10195327147334 (unit), Lot Numbers: 22GBJ096, 22GBJ097, 22HBR769, 22KBN934, 23ABH521, 23ABM586, 23BBR709, 23DBL344; c) REF DYKM1425, UDI/DI 40889942511236 (case), 10889942511235 (unit), Lot Numbers: 22DLA695, 22FLA284, 22GLA016, 22ILA012, 22ILA463, 22KLA336, 23ALA341, 23BLA132, 23DLB048, 23ELA454, 23FLA774, 23HLA165, 23ILB030, 23JLA435; d) REF DT18700, UDI/DI 653160275087 (case), 10653160275084 (unit), Lot Numbers: 23EBC489; e) REF DYNJ53966A, UDI/DI 40889942964681 (case), 10889942964680 (unit), Lot Numbers: 23CMB869, 23DMG880, 23EMG449, 23FMC889, 23HMA233, 23IMD181; f) REF DYNJ53966AH, UDI/DI 40889942964681 (case), 10889942964680 (unit), Lot Numbers: 23CMB869, 23DMG880, 23EMG449, 23FMC889, 23HMA233, 23IMD181, g) REF CDS982034R, UDI/DI 40195327003740 (case), 10195327003739 (unit), Lot Numbers: 21LBB488, 21LBC635, 22HBW422; h) REF CDS982034S, UDI/DI 40195327295364 (case), 10195327295363(unit), Lot Numbers: 23ABB710, 23BBA114, 23EBB482; i) REF DYNJ39331B, UDI/DI 40889942731580 (case), 10889942731589 (unit), Lot Numbers: 22HBH194, 22JBE708, 22LBL321, 23GBV891, 23IBA384; j) REF DYNJ37709J, UDI/DI 40193489376075 (case), 10193489376074 (unit), Lot Numbers: 22FMG179; k) REF CDS983912V, UDI/DI 40195327057146 (case), 10195327057145 (unit), Lot Numbers: 22BBX974, 22DBG451, 22DBO438, 22FBM809; l) REF CDS983912W, UDI/DI 40195327238408 (case), 10195327238407 (unit), Lot Numbers: 22KBI248, 23CBC518, 23DBM244; m) REF CDS983912X, UDI/DI 40195327403141 (case), 10195327403140 (unit), Lot Numbers: 23EBK644; n) REF CDS983912Y, UDI/DI 40195327417827 (case), 10195327417826 (unit), Lot Numbers: 23FBS625, 23HBD741, 23HBO315, 23IBC397, 23IBM310; o) REF DYNJ41417J, UDI/DI 40195327220991 (case), 10195327220990 (unit), Lot Numbers: 23FBQ267; p) REF CDS860091A, UDI/DI 40884389018324 (case), 10884389018323 (unit), Lot Numbers: 22ABW443, 22CBU907, 22FMA320, 22GMH940, 22IMI179, 22KMA029, 23AMJ550, 23CMF095, 23FMI870, 23GMF353; q) REF DYNJ46222M, UDI/DI 40195327437566 (case), 10195327437565 (unit), Lot Numbers: 23GBP791; r) REF DYNJ80578A, UDI/DI 40195327063819 (case), 10195327063818 (unit), Lot Numbers: 22FBO880; s) REF DYNJ67217D, UDI/DI 40195327278022 (case), 10195327278021 (unit), Lot Numbers: 23DBC699, 23EBB789, 23GBC854, 23GBP633; t) REF CDS982518O, UDI/DI 40195327247387 (case), 10195327247386 (unit), Lot Numbers: 23ABD137; u) REF CDS982518P, UDI/DI 40195327318858 (case), 10195327318857 (unit), Lot Numbers: 23BBM210; v) REF DYKM1438, UDI/DI 40889942529965 (case), 10889942529964 (unit), Lot Numbers: 22DDB583, 22FDA732, 22HDA409, 22JDA278, 22LDA778, 23BDB559, 23FDC186, 23IDA954; w) REF DYNJ906885B, UDI/DI 40193489972543 (case), 10193489972542 (unit), Lot Numbers: 22GBF087; x) REF SUT13535, UDI/DI 40193489440271 (case), 10193489440270 (case), Lot Numbers: 23GBD750; y) REF DYKM1404, UDI/DI 40889942473831 (case), 10889942473830 (unit), Lot Numbers: 22JBQ565, 23CBG138, 23EBO035, 23EBW986, 23GBP589; z) REF DYNDJ1057A, UDI/DI 40888277204790 (case), 10888277204799 (unit), Lot Numbers: 23DBC974
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		 Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action MEDLINE issued an IMMEDIATE ACTION REQUIRED NURSE ASSIST PRODUCT RECALL notice to its consignees on 11/16/2023 via USPS first class mail and email. The notice explained the problem, requested log on to their portal to identify the products and check their inventory so the product could be quarantined. Once Medline receives the completed response form, over-labels will be shipped to the consignee. Medline Industries, LP instructed customers to over-label the convenience kits with a warning label indicating to remove the sodium chloride irrigation or Sterile water and replace from a different sterile supply. Distributors or consignees who further distributed the affected products were directed to notify their customers. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Quantity in Commerce 3297 units
Distribution Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
Total Product Life Cycle TPLC Device Report
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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