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Class 2 Device Recall Medline Probe Cover Kits |
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| Date Initiated by Firm |
May 18, 2023 |
| Date Posted |
July 20, 2023 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-2181-2023 |
| Recall Event ID |
92466 |
| Product Classification |
General surgery tray - Product Code LRO
|
| Product |
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:
a) BLOCK SUPPLIES NDL CNTR, Model Number DYNJRA1755;
b) VNUS TEST KIT CFP-LF, Model Number DYNJTESTCFP4;
c) ULTRASOUND PIV BUNDLE, Model Number IV8635D;
d) ULTRASOUND GUIDED PIV KIT, Model Number IVS3300;
e) ULTRASOUND GUIDED PIV INSERTIO, Model Number IVS3485A;
f) EPIV PROCEDURE TRAY, Model Number IVS3825;
g) ULTRASOUND GUIDED PIV INSERTIO, Model Number IVS3840A;
h) RADIOLOGY TRAY, Model Number MNS11625;
i) BEDSIDE PROCEDURE PREP KIT, Model Number MNS7695A;
j) NGHS EVOR ANGIO PACK, Model Number NG410A;
k) PICC INSERT KIT-LESS THAN 3 FR, Model Number PHS41739A;
l) RADIOLOGY SPECIALS PACK, Model Number PHS479840M;
m) HYBRID OR PACK, Model Number SYNJ10303B;
n) TVS4500 MULTI PURPOSE VEIN, Model Number TVS4500A;
o) TVS4500 MULTI PURPOSE VEIN, Model Number TVS4500B;
p) VC PROCEDURE KIT, Model Number VC-PK |
| Code Information |
all lots within expiry, distributed from Medline between December 2017 - May 2023:
a) Model Number DYNJRA1755, UDI/DI (EA) 10193489842845, UDI/DI (CS) 40193489842846;
b) Model Number DYNJTESTCFP4, UDI/DI (EA) 10193489472813, UDI/DI (CS) 40193489472814;
c) Model Number IV8635D, UDI/DI (EA) 10653160990260, UDI/DI (CS) 40653160990261;
d) Model Number IVS3300, UDI/DI (EA) 10653160307662, UDI/DI (CS) 40653160307663;
e) Model Number IVS3485A, UDI/DI (EA) 10653160990154, UDI/DI (CS) 40653160990155;
f) Model Number IVS3825, UDI/DI (EA) 10653160330752, UDI/DI (CS) 40653160330753;
g) Model Number IVS3840A, UDI/DI (EA) 10193489476736, UDI/DI (CS) 40193489476737;
h) Model Number MNS11625, UDI/DI (EA) 10653160322139, UDI/DI (CS) 40653160322130;
i) Model Number MNS7695A, UDI/DI (EA) 10653160343455, UDI/DI (CS) 40653160343456;
j) Model Number NG410A, UDI/DI (EA) 10889942945887, UDI/DI (CS) 40889942945888;
k) Model Number PHS41739A, UDI/DI (EA) 10889942906802, UDI/DI (CS) 40889942906803;
l) Model Number PHS479840M, UDI/DI (EA) 10193489682724, UDI/DI (CS) 40193489682725;
m) Model Number SYNJ10303B, UDI/DI (EA) 10193489373745, UDI/DI (CS) 40193489373746;
n) Model Number TVS4500A, UDI/DI (EA) 10816982023374, UDI/DI (CS) 40816982023375;
o) Model Number TVS4500B, UDI/DI (EA) 10195327223564, UDI/DI (CS) 40195327223565;
p) Model Number VC-PK, UDI/DI (EA) 10195327176891, UDI/DI (CS) 40195327176892;
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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 |
Karin Johnson
886-359-1704
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Manufacturer Reason
for Recall |
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
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FDA Determined
Cause 2 |
Device Design |
| Action |
Medline distributed their recall notices to their consignees beginning on 05/18/2023 by letter. The notices explained the problem, and the risk and requested the destruction of the products. Distributors were directed to notify their consignees, have the customers document and destroy any affected product, and include your customers quantities on the response form.
Beginning on 05/23/2023, Medline issued another notice to a separate group of consignees requesting that the kits be over labeled. Distributors were directed to notify the customers and have them return any affected product to the distributor for collection and return to Medline.
Questions: please contact the Recall Department at 866-359-1704 |
| Quantity in Commerce |
# included in 3,740,814 units total |
| Distribution |
Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia. |
| 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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