| Class 2 Device Recall Medline Probe Cover Kits | |
Date Initiated by Firm | May 18, 2023 |
Date Posted | July 20, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2162-2023 |
Recall Event ID |
92466 |
Product Classification |
Cardiac catheterization kit - Product Code OES
|
Product | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATH PACK, Model Number DYNJ83105;
b) TESIO, Model Number DYNJ83251;
c) ANGIOGRAPHY PACK-LF, Model Number DYNJ83508;
d) OR ANGIOGRAM PACK-LF, Model Number DYNJ83656;
e) FERRELL-DUCAN ANGIO, Model Number DYNJ83696;
f) ANGIO KIT PACK, Model Number DYNJ83746;
g) M&E ARTERIOGRAM PK, Model Number DYNJ83815;
h) ANGIOGRAPHY CV RAD PACK, Model Number DYNJ83918;
i) ANGIO PACK, Model Number DYNJ83936;
j) ARTERIOGRAM - SUMMIT PACK, Model Number DYNJ84040;
k) ANGIO PACK, Model Number DYNJ84190;
l) ANGIO, Model Number DYNJ902507C;
m) ANGIO, Model Number DYNJ902507D;
n) ANGIO, Model Number DYNJ905151B;
o) PACK ANGIOPLASTY CV,8405, Model Number DYNJ906766B;
p) (13) STC IVC FILTER/ANGIOGRAM, Model Number DYNJ908249A;
q) OR ANGIOGRAM, Model Number DYNJ909267;
r) RADIOLOGY PACK #108402-LF, Model Number DYNJVB1000;
s) HYBRID OR PACK, Model Number SYNJ10303C |
Code Information |
all lots within expiry, distributed from Medline between December 2017 - May 2023:
a) Model Number DYNJ83105, UDI/DI (EA)10195327231514, UDI/DI (CS)40195327231515;
b) Model Number DYNJ83251, UDI/DI (EA)10195327248659, UDI/DI (CS)40195327248650;
c) Model Number DYNJ83508, UDI/DI (EA)10195327273163, UDI/DI (CS)40195327273164;
d) Model Number DYNJ83656, UDI/DI (EA)10195327288228, UDI/DI (CS)40195327288229;
e) Model Number DYNJ83696, UDI/DI (EA)10195327299125, UDI/DI (CS)40195327299126;
f) Model Number DYNJ83746, UDI/DI (EA)10195327300692, UDI/DI (CS)40195327300693;
g) Model Number DYNJ83815, UDI/DI (EA)10195327311018, UDI/DI (CS)40195327311019;
h) Model Number DYNJ83918, UDI/DI (EA)10195327313807, UDI/DI (CS)40195327313808;
i) Model Number DYNJ83936, UDI/DI (EA)10195327318550, UDI/DI (CS)40195327318551;
j) Model Number DYNJ84040, UDI/DI (EA)10195327329709, UDI/DI (CS)40195327329700;
k) Model Number DYNJ84190, UDI/DI (EA)10195327341961, UDI/DI (CS)40195327341962;
l) Model Number DYNJ902507C, UDI/DI (EA)10195327137885, UDI/DI (CS)40195327137886;
m) Model Number DYNJ902507D, UDI/DI (EA)10195327336561, UDI/DI (CS)40195327336562;
n) Model Number DYNJ905151B, UDI/DI (EA)10195327219963, UDI/DI (CS)40195327219964;
o) Model Number DYNJ906766B, UDI/DI (EA)10195327250195, UDI/DI (CS)40195327250196;
p) Model Number DYNJ908249A, UDI/DI (EA)10195327240509, UDI/DI (CS)40195327240500;
q) Model Number DYNJ909267, UDI/DI (EA)10195327314613, UDI/DI (CS)40195327314614;
r) Model Number DYNJVB1000, UDI/DI (EA)10193489800999, UDI/DI (CS)40193489800990;
s) Model Number SYNJ10303C, UDI/DI (EA)10195327118891, UDI/DI (CS)40195327118892 |
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 | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
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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