| | Class 2 Device Recall Medtronic |  |
| Date Initiated by Firm | March 19, 2024 |
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| Date Posted | May 10, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1805-2024 |
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| Recall Event ID |
94274 |
| 510(K)Number | K022272 |
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| Product Classification |
Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
|
| Product | Medtronic Venous Cannulae:
a) DLP 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120,
b) DLP 24 Fr. Malleable Single Stage Venous Cannula, Model Number 68124,
c) DLP 28 Fr. Malleable Single Stage Venous Cannula, Model Number 68128,
d) DLP 30 Fr. Malleable Single Stage Venous Cannula, Model Number 68130,
e) DLP 34 Fr. Malleable Single Stage Venous Cannula, Model Number 68134,
f) DLP 12 Fr. Single Stage Venous Cannula, Model Number 67312,
g) DLP 16 Fr. Single Stage Venous Cannula, Model Number 67316,
h) DLP 16 Fr. Single Stage Venous Cannula, Model Number 67516,
i) DLP 18 Fr. Single Stage Venous Cannula, Model Number 66118,
j) DLP 18 Fr. Single Stage Venous Cannula, Model Number 67318,
k) DLP 20 Fr. Single Stage Venous Cannula, Model Number 67320,
l) DLP 20 Fr. Single Stage Venous Cannula, Model Number 69320,
m) DLP 20 Fr. Single Stage Venous Cannula, Model Number 67520,
n) DLP 22 Fr. Single Stage Venous Cannula, Model Number 66122,
o) DLP 22 Fr. Single Stage Venous Cannula, Model Number 67522,
p) DLP 24 Fr. Single Stage Venous Cannula, Model Number 67524,
q) DLP 26 Fr. Single Stage Venous Cannula, Model Number 67526,
r) DLP 28 Fr. Single Stage Venous Cannula, Model Number 66128,
s) DLP 28 Fr. Single Stage Venous Cannula, Model Number 39628,
t) DLP 28 Fr. Single Stage Venous Cannula, Model Number 67528,
u) DLP 30 Fr. Single Stage Venous Cannula, Model Number 66130,
v) DLP 31 Fr. Single Stage Venous Cannula, Model Number 69331,
w) DLP 32 Fr. Single Stage Venous Cannula, Model Number 66132,
x) DLP 34 Fr. Single Stage Venous Cannula, Model Number 67534,
y) DLP 36 Fr. Single Stage Venous Cannula, Model Number 66236,
z) MC2 28/36 Fr. Two Stage Venous Cannula, Model Number 91228,
aa) MC2 29/37 Fr. Two Stage Venous Cannula, Model Number 91229C,
bb) MC2 32/40 Fr. Two Stage Venous Cannula, Model Number 91263,
cc) MC2 32/40 Fr. Two Stage Venous Cannula, Model Number 91240C,
dd) MC2 32/40 Fr. Two Stage Venous Cannula, Model Number 91263C,
ee) MC2 34/46 Fr. Two Stage Venous Cannula, Model Number 91246,
ff) MC2 34/46 Fr. Two Stage Venous Cannula, Model Number 91246C,
gg) MC2 36/46 Fr. Two Stage Venous Cannula, Model Number 91236C,
hh) MC2 36/51 Fr. Two Stage Venous Cannula, Model Number 91251,
ii) MC2 36/51 Fr. Two Stage Venous Cannula, Model Number 91251C,
jj) VC2" 34/38 Fr. Venous Cannula, Model Number 93438,
kk) VC2" 34/48 Fr. Venous Cannula, Model Number 93448C |
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| Code Information |
a) Model Number 68120, GTIN 20613994879435, Lot Numbers: 2023041436;
b) Model Number 68124, GTIN 00613994879417, Lot Numbers: 2023041441, 2023041448;
b) Model Number 68124, GTIN 00681490466349, Lot Numbers: 2023041441, 2023041448;
b) Model Number 68124, GTIN 20613994879411, Lot Numbers: 2023041441, 2023041448, 202306C008;
c) Model Number 68128, GTIN 00613994879394, Lot Numbers: 2023041040;
c) Model Number 68128, GTIN 00681490466363, Lot Numbers: 2023041388;
c) Model Number 68128, GTIN 20613994879398, Lot Numbers: 2023041040, 2023041388, 202306C010, 202306C011;
d) Model Number 68130, GTIN 20613994879381, Lot Numbers: 2023041390, 202308C131;
e) Model Number 68134, GTIN 20613994879367, Lot Numbers: 2023041431;
f) Model Number 67312, GTIN 00613994879325, Lot Numbers: 2023041423;
f) Model Number 67312, GTIN 00673978184180, Lot Numbers: 2023040074;
f) Model Number 67312, GTIN 20613994879329, Lot Numbers: 2023040073, 2023040074, 2023041423;
g) Model Number 67316, GTIN 00613994879301, Lot Numbers: 2023040076, 2023041416;
g) Model Number 67316, GTIN 20613994879305, Lot Numbers: 2023040076, 2023041416, 202305C264;
h) Model Number 67516, GTIN 00613994879301, Lot Numbers: 2023040076, 2023041416;
h) Model Number 67516, GTIN 20613994879305, Lot Numbers: 2023040076, 2023041416, 202305C264;
i) Model Number 66118, GTIN 00613994878526, Lot Numbers: 2023041014;
i) Model Number 66118, GTIN 20613994878520, Lot Numbers: 2023041014, 2023041015;
j) Model Number 67318, GTIN 00613994879295, Lot Numbers: 2023040077;
j) Model Number 67318, GTIN 00673978184241, Lot Numbers: 2023040077, 2023041391;
j) Model Number 67318, GTIN 20613994879299, Lot Numbers: 2023040077, 2023041391, 202305C256;
k) Model Number 67320, GTIN 00613994879288, Lot Numbers: 2023031377;
k) Model Number 67320, GTIN 00673978184258, Lot Numbers: 2023031377;
k) Model Number 67320, GTIN 20613994879282, Lot Numbers: 2023031377, 202307C051;
l) Model Number 69320, GTIN 00613994879233, Lot Numbers: 2023041422;
l) Model Number 69320, GTIN 00673978184609, Lot Numbers: 2023041422;
l) Model Number 69320, GTIN 20613994879237, Lots Numbers: 2023041422, 2023041438, 202306C014, 202306C015;
m) Model Number 67520, GTIN 00613994878359, Lot Numbers: 2023040082;
m) Model Number 67520, GTIN 20613994878353, Lot Numbers: 2023040082;
n) Model Number 66122, GTIN 20613994878544, Lot Numbers: 2023041016;
o) Model Number 67522, GTIN 00613994878366, Lot Numbers: 2023040083, 2023040565;
o) Model Number 67522, GTIN 00673978184326, Lot Numbers: 2023040083, 2023040565;
o) Model Number 67522, GTIN 20613994878360, Lot Numbers: 2023040083, 2023040565, 202307C050;
p) Model Number 67524, GTIN 00673978184333, Lot Numbers: 2023040084;
p) Model Number 67524, GTIN 20613994878377, Lot Numbers: 2023040084, 2023040566, 202305C257;
q) Model Number 67526, GTIN 00673978165585, Lot Numbers: 2023040569;
q) Model Number 67526, GTIN 20613994878384, Lot Numbers: 2023040569, 202308C082;
r) Model Number 66128, GTIN 00613994878571, Lot Numbers: 2023041020;
r) Model Number 66128, GTIN 20613994878575, Lot Numbers: 2023041020, 202305C177;
s) Model Number 39628, GTIN
t) Model Number 67528, GTIN 20613994878391, Lot Numbers: 2023041036;
u) Model Number 66130, GTIN 00613994878588, Lot Numbers: 2023040555, 202305C217;
u) Model Number 66130, GTIN 20613994878582, Lot Numbers: 2023040555, 2023041414, 202305C217, 202305C218;
v) Model Number 69331, GTIN 20613994879183, Lot Numbers: 2023041444, 202307C012;
w) Model Number 66132, GTIN 00613994878601, Lot Numbers: 2023041428;
w) Model Number 66132, GTIN 20613994878605, Lot Numbers: 2023041412, 2023041428, 202305C227;
x) Model Number 67534, GTIN 20613994878421, Lot Numbers: 2023031249, 202308C079;
y) Model Number 66236, GTIN 20613994878643, Lot Numbers: 2023041398, 202305C222;
z) Model Number 91228, GTIN 20643169463015, Lot Numbers: 2023041070;
aa) Model Number 91229C, GTIN 20643169463060, Lot Numbers: 2023041071;
bb) Model Number 91263, GTIN 00673978187761, Lot Numbers: 2023041095;
bb) Model Number 91263, GTIN 20613994887454, Lot Numbers: 2023041095, 202306C105;
cc) Model Number 91240C, GTIN 00613994887306, Lot Numbers: 2023041082, 2023041083, 2023041084;
cc) Model Number 91240C, GTIN 20613994887300, Lot Numbers: 2023041079, 2023041081, 2023041082, 2023041083, 2023041084, 2023041087, 2023041088, 202306C074, 202306C075, 202306C076, 202306C077;
dd) Model Number 91263C, GTIN 20613994887447, Lot Numbers: 2023040116, 2023041097, 202306C103;
ee) Model Number 91246, GTIN 00613994887535, Lot Numbers: 2023041089;
ee) Model Number 91246, GTIN 20613994887539, Lot Numbers: 2023041089, 202306C101;
ff) Model Number 91246C, GTIN 00613994887528, Lot Numbers: 2023041090;
ff) Model Number 91246C, GTIN 20613994887522, Lot Numbers: 2023041090, 202306C123;
gg) Model Number 91236C, GTIN 00613994887344, Lot Numbers: 2023041072;
gg) Model Number 91236C, GTIN 20613994887348, Lot Numbers: 2023041072, 202306C065;
hh) Model Number 91251, GTIN 00613994887498, Lot Numbers: 2023041092, 2023041094;
hh) Model Number 91251, GTIN 20613994887492, Lot Numbers: 2023041092, 2023041094;
ii) Model Number 91251C, GTIN 00613994887481, Lot Numbers: 2023040618, 202306C102;
ii) Model Number 91251C, GTIN 20613994887485, Lot Numbers: 2023040617, 2023040618, 202306C102;
jj) Model Number 93438, GTIN 00673978188201, Lot Numbers: 2023040626;
jj) Model Number 93438, GTIN 20613994887034, Lot Numbers: 2023040626;
kk) Model Number 93448C, GTIN 20613994887256, Lot Numbers: 2023040627
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Recalling Firm/
Manufacturer |
Medtronic Perfusion Systems
7611 Northland Dr N
Brooklyn Park MN 55428-1088
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| For Additional Information Contact | Krystin Hayward
508-261-6512 |
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Manufacturer Reason
for Recall | Potential for unsealed sterile packing. |
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FDA Determined
Cause 2 | Process control |
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| Action | Medtronic issued an Urgent Medical Device Recall notice to its consignees on 03/19/2024 via letter (UPS). The notice explained the issue, potential risk, and requested the consignee identify and return the product. Consignee was directed to forward the notice to all affected parties.
For questions, the consignee was directed to contact their Medtronic field representative. |
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| Quantity in Commerce | 17221 units |
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| Distribution | Worldwide 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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| 510(K) Database | 510(K)s with Product Code = DWF
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