| | Class 1 Device Recall Medline Fluid Delivery Set |  |
| Date Initiated by Firm | December 16, 2024 |
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| Date Posted | January 15, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0765-2025 |
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| Recall Event ID |
95988 |
| Product Classification |
Cardiovascular procedure kit - Product Code OEZ
|
| Product | Medline Fluid Delivery Set with Drip Chamber:
1) MTO,135,YELLOW,MICRO,SPK-MAIMONIDES, Item Number: 60130527;
2) MTO,ANGIO,DOUBLE,SPIKE,KIT,KENNEDY HLTH, Item Number: 65111341;
3) MTO,ANGIO,SINGLE,SPIKE,KIT, Item Number: 65232486;
4) MTO,ANGIO,SINGLE,SPIKE,KIT,GOOD,SAM, Item Number: 65071193;
5) MTO,NEURO,FLUSH,SPIKE,KIT,BLUE,FLORIDA, Item Number: 600604422;
6) MTO,NEURO,KIT,-,JERSEY,SHORE PG, Item Number: 60100045;
7) MTO,RADIOLOGY,KIT,HAMOT MED CEN, Item Number: 650801715;
8) MTS,135,CDS,IV,TUBE-JEFFERSON UNIV., Item Number: 60232481;
9) MTS,135,YELLOW,MICRO,SPIKE,LUTHERAN MED, Item Number: 60120583;
10) MTS,ANGIO,NEURO,KIT,NORTH SHORE UNIV, Item Number: 601403920;
11) MTS,CUST. FILTER-NEWYORK UNIVERSITY, Item Number: 62140602;
12) MTS,INTERV,NEURO,KIT-WESTCHESTER,MC, Item Number: 602301614;
13) MTS,NEU,NORTH SHORE HOSPITAL, Item Number: 6010771601;
14) MTS,NEURO,KIT, Item Number: 600602914;
15) MTS,NEURO,KIT,2,NEWENGLAND MED CTR, Item Number: 601400111;
16) MTS,NEURO,KIT,YLW&RED,FLORIDA HOSP, Item Number: 600604423;
17) MTS,NEURO,KIT-JOHN,F,KENNEDY MED CENTER, Item Number: 60110552;
18) MTS,NEURO,KIT-OVERLOOK HOSPITAL PG, Item Number: 60150035;
19) MTS,NEURO,SPIKE,KIT,CAPITAL HLTHSYS-FULD, Item Number: 60182723;
20) MTS,NEURO-RADIOLOGY,KIT-YALE-NEWHAVEN, Item Number: 602500214;
21) MTS,STROKE/EMBO,KIT,NORTH SHORE UNIV, Item Number: 601403921;
22) MTS,YELLOW,/,RED,MULTILINE,KIT,MAIMONIDE, Item Number: 601305210;
23) MTS,YELLOW,/,RED,MULTILINE,KIT,MAIMONIDE, Item Number: 601400110; |
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| Code Information |
1) 60130527 UDI-D:10193489046465(each), 20193489046462(case), Lot Number:0000133032;
2) 65111341 UDI-D:10193489061314(each), 20193489061311(case), Lot Number:0000129541;
3) 65111341 UDI-D:10193489061314(each), 20193489061311(case), Lot Number:0000134701;
4) 65232486 UDI-D:10193489063950(each), 20193489063957(case), Lot Number:0000129544;
5) 65232486 UDI-D:10193489063950(each), 20193489063957(case), Lot Number:0000128715;
6) 65232486 UDI-D:10193489063950(each), 20193489063957(case), Lot Number:0000133060;
7) 65232486 UDI-D:10193489063950(each), 20193489063957(case), Lot Number:0000131657;
8) 65232486 UDI-D:10193489063950(each), 20193489063957(case), Lot Number:0000135723;
9) 65232486 UDI-D:10193489063950(each), 20193489063957(case), Lot Number:0000135294;
10) 65071193 UDI-D:10193489060904(each), 20193489060901(case), Lot Number:0000130171;
11) 600604422 UDI-D:10193489070224(each), 20193489070221(case), Lot Number:0000135606;
12) 600604422 UDI-D:10193489070224(each), 20193489070221(case), Lot Number:0000134729;
13) 600604422 UDI-D:10193489070224(each), 20193489070221(case), Lot Number:0000137115;
14) 600604422 UDI-D:10193489070224(each), 20193489070221(case), Lot Number:0000130833;
15) 600604422 UDI-D:10193489070224(each), 20193489070221(case), Lot Number:0000131669;
16) 600604422 UDI-D:10193489070224(each), 20193489070221(case), Lot Number:0000129513;
17) 600604422 UDI-D:10193489070224(each), 20193489070221(case), Lot Number:0000128721;
18) 60100045 UDI-D:10193489044928(each), 30193489044922(case), Lot Number:0000129523;
19) 60100045 UDI-D:10193489044928(each), 30193489044922(case), Lot Number:0000132393;
20) 60100045 UDI-D:10193489044928(each), 30193489044922(case), Lot Number:0000134940;
21) 60100045 UDI-D:10193489044928(each), 30193489044922(case), Lot Number:0000144158;
22) 60100045 UDI-D:10193489044928(each), 30193489044922(case), Lot Number:0000139082;
23) 650801715 UDI-D:10193489075458(each), 20193489075455(case), Lot Number:0000130138;
24) 650801715 UDI-D:10193489075458(each), 20193489075455(case), Lot Number:0000132350;
25) 650801715 UDI-D:10193489075458(each), 20193489075455(case), Lot Number:0000135736;
26) 60232481 UDI-D:10193489053326(each), 30193489053320(case), Lot Number:0000129534;
27) 60120583 UDI-D:10193489045864(each), 30193489045868(case), Lot Number:0000133660;
28) 60120583 UDI-D:10193489045864(each), 30193489045868(case), Lot Number:0000136501;
29) 60120583 UDI-D:10193489045864(each), 30193489045868(case), Lot Number:0000131600;
30) 601403920 UDI-D:10193489071498(each), 30193489071492(case), Lot Number:0000131376;
31) 601403920 UDI-D:10193489071498(each), 30193489071492(case), Lot Number:0000130940;
32) 62140602 UDI-D:10193489057805(each), 30193489057809(case), Lot Number:0000132222;
33) 62140602 UDI-D:10193489057805(each), 30193489057809(case), Lot Number:0000141215;
34) 602301614 UDI-D:10193489072754(each), 30193489072758(case), Lot Number:0000133659;
35) 6010771601 UDI-D:10193489099843(each), 30193489099847(case), Lot Number:0000127859;
36) 600602914 UDI-D:10193489070170(each), 30193489070174(case), Lot Number:0000135717;
37) 600602914 UDI-D:10193489070170(each), 30193489070174(case), Lot Number:0000128447;
38) 601400111 UDI-D:10193489071344(each), 30193489071348(case), Lot Number:0000133121;
39) 601400111 UDI-D:10193489071344(each), 30193489071348(case), Lot Number:0000130573;
40) 600604423 UDI-D:10193489070231(each), 30193489070235(case), Lot Number:0000128607;
41) 600604423 UDI-D:10193489070231(each), 30193489070235(case), Lot Number:0000137751;
42) 60110552 UDI-D:10193489045611(each), 30193489045615(case), Lot Number:0000131878;
43) 60110552 UDI-D:10193489045611(each), 30193489045615(case), Lot Number:0000130577;
44) 60110552 UDI-D:10193489045611(each), 30193489045615(case), Lot Number:0000138084;
45) 60150035 UDI-D:10193489048292(each), 30193489048296(case), Lot Number:0000130187;
46) 60150035 UDI-D:10193489048292(each), 30193489048296(case), Lot Number:0000131883;
47) 60150035 UDI-D:10193489048292(each), 30193489048296(case), Lot Number:0000143095;
48) 60182723 UDI-D:10193489049817(each), 30193489049811(case), Lot Number:0000130988;
49) 602500214 UDI-D:10193489072815(each), 30193489072819(case), Lot Number:0000127874;
50) 601403921 UDI-D:30193489071508(each), 30193489071508(case), Lot Number:0000131619;
51) 601403921 UDI-D:30193489071508(each), 30193489071508(case), Lot Number:0000133025;
52) 601403921 UDI-D:30193489071508(each), 30193489071508(case), Lot Number:0000136559;
53) 601305210 UDI-D:10193489070989(each), 30193489070983(case), Lot Number:0000130984;
54) 601400110 UDI-D:10193489071337(each), 30193489071331(case), Lot Number:0000128757;
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Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
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| For Additional Information Contact | Haley Barclay
866-359-1704 |
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Manufacturer Reason
for Recall | Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than the micro drip chamber. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | An IMMEDIATE ACTION REQUIRED MEDICAL DEVICE RECALL notification letter dated 12/16/24 was sent to customers.
REQUIRED ACTION:
1. Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. Quarantine all affected product immediately.
2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form.
3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable.
The login for completing the response form is:
Website link: https://recalls.medline.com Recall Reference #: R-24-270-FG
Recall Code:
4. If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication.
If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Update:
A follow-up letter titled IMMEDIATE ACTION REQUIRED dated 2/11/25 was sent to customers.
Medline would like to update our action to instruct you to please destroy all impacted convenience kits and Medline will provide replacement kit(s) with the correct Fluid Delivery Set.
REQUIRED ACTION:
1. Immediately check your stock for the affected kit number(s) and lot number(s) listed on the attachment. Please destroy all affected kits.
2. Please complete and return the enclosed destruction form listing the quantity of affected kits destroyed. Even if you do not have any affected product, please complete and return the form.
3. Upon receipt of your completed destruction form, Medline will issue replacem |
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| Quantity in Commerce | 3930 units |
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| Distribution | US Nationwide Distribution |
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| 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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