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Class 2 Device Recall Medtronic |
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| Date Initiated by Firm |
March 19, 2024 |
| Date Posted |
May 10, 2024 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1793-2024 |
| Recall Event ID |
94274 |
| 510(K)Number |
K840002
|
| Product Classification |
Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
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| Product |
Medtronic Arterial Cannulae packaged as:
a) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020;
b) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80220;
c) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 82020;
d) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 87120;
e) DLP¿ Curved Metal Tip Arterial Cannula 22 Fr. , Model Number 80222;
f) DLP¿ Curved Metal Tip Arterial Cannula 22 Fr. , Model Number 87122;
g) DLP¿ Curved Tip Arterial Cannula 20 Fr., Model Number 87220;
h) DLP¿ Curved Tip Arterial Cannula 22 Fr., Model Number 87222;
i) DLP" One-Piece Arterial Cannulae, Pediatric 6 Fr, Model Number 77006;
j) DLP" One-Piece Pediatric Arterial Cannula 6 Fr, Model Number 77206;
k) DLP" One-Piece Pediatric Arterial Cannula 8 Fr, Model Number 77008;
l) DLP" One-Piece Pediatric Arterial Cannula 10 Fr, Model Number 77010;
m) DLP" One-Piece Pediatric Arterial Cannula 10 Fr, Model Number 77110;
n) DLP" One-Piece Pediatric Arterial Cannula 12 Fr, Model Number 77112;
o) EOPA" Elongated One Piece Arterial Cannula 20 Fr., Model Number 77420;
p) EOPA" Elongated One Piece Arterial Cannula 22 Fr., Model Number 77422;
q) EOPA" Elongated One Piece Arterial Cannula 22 Fr., Model Number 77522;
r) EOPA" Elongated One Piece Arterial Cannula 22 Fr., Model Number 77622;
s) EOPA" Elongated One Piece Arterial Cannula 24 Fr., Model Number 77524;
t) Select Series" Angled Tip Arterial Cannula 24Fr., Model Number 72424;
u) Select Series" Straight Tip Arterial Cannula 20 Fr., Model Number 72120;
v) Select Series" Straight Tip Arterial Cannula 24 Fr., Model Number 72224 |
| Code Information |
a) Model Number 80020, GTIN 20643169485703, Lot Numbers: 2023040597, 2023041061, 202305C247;
b) Model Number 80220, GTIN 20643169485734, Lot Numbers: 2023031390, 2023040098, 202305C249, 202310C155;
c) Model Number 82020, GTIN 20643169485536, Lot Numbers: 2023041063, 2023041396, 202305C253;
d) Model Number 87120, GTIN 00673978187105, Lot Numbers: 2023040600; GTIN 20613994879114, Lot Numbers: 2023040600, 2023041066, 202306C018;
e) Model Number 80222, GTIN 20643169485741, Lot Numbers: 2023041062, 202308C058;
f) Model Number 87122, GTIN 00613994879103, Lot Numbers: 2023040601; GTIN 20613994879107, Lot Numbers: 2023040601, 2023041067, 202306C017;
g) Model Number 87220, GTIN 00643169485563, Lot Numbers: 2023031282, 2023040602, 2023041068; GTIN 20643169485567, Lot Numbers: 2023031282, 2023031283, 2023031391, 2023040602, 2023041068, 202306C006, 202306C247;
h) Model Number 87222, GTIN 00643169485570, Lot Numbers: 2023041408; GTIN 20643169485574, Lot Numbers: 2023041069, 2023041408, 202306C007;
i) Model Number 77006, GTIN 20763000091013, Lot Numbers: 2023040943, 202306C056;
j) Model Number 77206, GTIN 20763000091020, Lot Numbers: 2023041347, 202308C108;
k) Model Number 77008, GTIN 20763000091105, Lot Numbers: 2023040944, 2023040946, 02306C020, 202308C084;
l) Model Number 77010, GTIN 20763000091112, Lot Numbers: 2023041337, 202306C023;
m) Model Number 77110, GTIN 00673978185989, Lot Numbers: 2023041342; GTIN 20763000091174, Lot Numbers: 2023041342, 202308C104;
n) Model Number 77112, GTIN 00673978186009, Lot Numbers: 2023041343; GTIN 20763000091181, Lot Numbers: 2023041343, 202308C106;
o) Model Number 77420, GTIN 20763000135625, Lot Numbers: 2023040668, 2023040671, 202306C032, 202307C005;
p) Model Number 77422, GTIN 20763000135632, Lot Numbers: 2023040966, 2023041355, 202306C043, 202306C046;
q) Model Number 77522, GTIN 20763000135557, Lot Numbers: 2023041361, 2023041364, 202306C051;
r) Model Number 77622, GTIN 00763000135676, Lot Numbers: 2023040971; GTIN 20763000135670, Lot Numbers: 2023040971, 2023040974, 2023040978, 2023040980, 202306C061, 202307C029, 202307C030;
s) Model Number 77524, GTIN 20763000135564, Lot Numbers: 2023041365, 202306C052;
t) Model Number 72424, GTIN 20643169485468, Lot Numbers: 2023040940;
u) Model Number 72120, GTIN 00643169485938, Lot Numbers: 2023041326; GTIN 20643169485932, lot Numbers: 2023041326, 202305C184;
v) Model Number 72224, GTIN 20613994879701, Lot Numbers: 2023041332 |
Recalling Firm/
Manufacturer |
Medtronic Perfusion Systems
7611 Northland Dr N
Brooklyn Park MN 55428-1088
|
| For Additional Information Contact |
Krystin Hayward
508-261-6512
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Manufacturer Reason
for Recall |
Potential for unsealed sterile packing.
|
FDA Determined
Cause 2 |
Process control |
| 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. |
| Quantity in Commerce |
13033 units |
| 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 and Original Applicant = DLP, INC.
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