| | Class 2 Device Recall Centurion |  |
| Date Initiated by Firm | April 08, 2024 |
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| Date Posted | August 28, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2767-2024 |
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| Recall Event ID |
94585 |
| 510(K)Number | K213481 |
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| Product Classification |
General surgery tray - Product Code LRO
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| Product | Centurion procedure kits, labeled as:
1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C;
2) ARTERIAL LINE TRAY-NO CATHETER, Pack Number ART1170;
3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220;
4) ARTHROGRAPH TRAY, Pack Number MNS12670A;
5) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455;
6) BIOPSY TRAY, Pack Number BT1060;
7) BIOPSY TRAY, Pack Number BT1015;
8) BIOPSY TRAY, Pack Number DYNDH1137C;
9) BIOPSY TRAY-LF, Pack Number SPEC4380;
10) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNJTS0214;
11) BREAST BIOPSY TRAY, Pack Number SPEC0130C;
12) CDP, INTRODUCER KIT 9F, Pack Number S5078BF09;
13) CHEST TUBE INSERTION TRAY, Pack Number CHT560;
14) CIRCUMCISION TRAY, Pack Number CIT7050C;
15) CT BIOPSY TRAY W/CHLORAPREP, Pack Number DYNJ05162;
16) CVC INSERT BUNDLE 16CM, Pack Number ECVC7860;
17) ER CHEST TUBE TRAY, Pack Number CHT1570A;
18) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150;
19) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297;
20) LOCAL INFILTRATION TRAY, Pack Number DYNDH1406;
21) LUMBAR PUNCTURE TRAY, Pack Number PT215;
22) LUMBAR TRAY, Pack Number SPEC0197B;
23) NICU PICC KIT, Pack Number CVI4575;
24) OB DELIVERY TRAY, Pack Number MNS10875A;
25) ON/OFF KIT, Pack Number DT8525;
26) PEDI ULTRASOUND GUIDED PIV KIT, Pack Number IVS3320;
27) PERIPHERAL BLOOD CULTURE KIT (1 SET), Pack Number DYNDH1910;
28) PERITONSILLAR ABSCESS TRAY, Pack Number MNS3560;
29) PORT ACCESS KIT, Pack Number DYNDC2945;
30) PORT ACCESS TRAY, Pack Number EBSI1241;
31) PORT INSERTION KIT, Pack Number MNS11590;
32) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A;
33) STEREOTACTIC TRAY, Pack Number MNS5785;
34) SUTURING SET, Pack Number SUT4020;
35) U.A.C. TRAY, Pack Number UVT125;
36) ULTRASOUND TRAY, Pack Number MNS5460;
37) UMBILICAL VES CATH INSERT TRAY, Pack Number UVT1080;
38) UMBILICAL VESSEL TRAY, Pack Number UVT1100A;
39) VAGINAL DELIVERY TRAY, Pack Number MNS11020A |
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| Code Information |
ART245C, Lot Number 2023101990;
ART1170, Lot Number 2022121990;
ART1170, Lot Number 2023012790;
ART1170, Lot Number 2023021590;
PT220, Lot Number 2021061490;
PT220, Lot Number 2022011090;
MNS12670A, Lot Number 2021060190;
MNS12670A, Lot Number 2022011090;
MNS12670A, Lot Number 2023022190;
MNS12670A, Lot Number 2023101890;
SUT20455, Lot Number 2021060190;
SUT20455, Lot Number 2022011090;
SUT20455, Lot Number 2023012390;
BT1060, Lot Number 2020062490;
BT1015, Lot Number 2021060190;
DYNDH1137C, Lot Number 2021091490;
DYNDH1137C, Lot Number 2022121990;
SPEC4380, Lot Number 2018102950;
SPEC4380, Lot Number 2023032390;
DYNJTS0214, Lot Number 2022061790;
DYNJTS0214, Lot Number 22121990;
SPEC0130C, Lot Number 2023022190;
S5078BF09, Lot Number 2020051850;
S5078BF09, Lot Number 2022092290;
CHT560, Lot Number 2018042790;
CHT560, Lot Number 2018050790;
CHT560, Lot Number 2018060490;
CHT560, Lot Number 2018080790;
CHT560, Lot Number 2018091190;
CHT560, Lot Number 2020032490;
CHT560, Lot Number 2020051990;
CHT560, Lot Number 2020062490;
CHT560, Lot Number 2020070190;
CHT560, Lot Number 2020071490;
CHT560, Lot Number 2020121590;
CHT560, Lot Number 2021042690;
CHT560, Lot Number 2021082390;
CHT560, Lot Number 2021091490;
CHT560, Lot Number 2022022490;
CHT560, Lot Number 2022050490;
CIT7050C, Lot Number 2023081480;
CIT7050C, Lot Number 2023101680;
CIT7050C, Lot Number 2024010590;
DYNJ05162, Lot Number 2020082050;
ECVC7860, Lot Number 2023101990;
CHT1570A, Lot Number 2021051290;
MNS12150, Lot Number 2019082790;
MNS12150, Lot Number 2020021290;
MNS12150, Lot Number 2020060290;
MNS12150, Lot Number 2020101390;
MNS12150, Lot Number 2020111790;
MNS12150, Lot Number 2020121890;
MNS12150, Lot Number 2021051290;
MNS12150, Lot Number 2021071390;
MNS12150, Lot Number 2022012890;
MNS12150, Lot Number 2022061790;
MNS12150, Lot Number 2022092290;
MNS12150, Lot Number 2023010690;
MNS12150, Lot Number 2023030690;
MNS12150, Lot Number 2023082490;
DYNDH1297, Lot Number 2019091750;
DYNDH1406, Lot Number 2023102790;
PT215, Lot Number 2018050350;
PT215, Lot Number 2018100950;
PT215, Lot Number 2018102950;
PT215, Lot Number 2019091750;
PT215, Lot Number 2019100450;
PT215, Lot Number 2020051850;
PT215, Lot Number 2020082050;
PT215, Lot Number 2020102850;
PT215, Lot Number 2020121550;
PT215, Lot Number 2021021850;
PT215, Lot Number 2021111850;
PT215, Lot Number 2022021650;
PT215, Lot Number 2022043050;
PT215, Lot Number 2022072990;
PT215, Lot Number 2023012390;
PT215, Lot Number 2023032790;
PT215, Lot Number 2023102790;
PT215, Lot Number 2023122090;
SPEC0197B, Lot Number 2018102950;
CVI4575, Lot Number 2023102590;
CVI4575, Lot Number 2023120190;
MNS10875A, Lot Number 2021060190;
DT8525, Lot Number 2023070590;
DT8525, Lot Number 2023092890;
DT8525, Lot Number 2024022090;
IVS3320, Lot Number 2021061490;
DYNDH1910, Lot Number 2023120480;
MNS3560, Lot Number 2021091490;
DYNDC2945, Lot Number 2023062190;
EBSI1241, Lot Number 2021051290;
MNS11590, Lot Number 2019072590;
MNS11590, Lot Number 2021010690;
MNS11590, Lot Number 2021061490;
MNS11590, Lot Number 2021122190;
MNS11590, Lot Number 2022050490;
MNS11590, Lot Number 2023032390;
MNS11590, Lot Number 2023062190;
MNS11590, Lot Number 2023101990;
DYNDC2859A, Lot Number 2021082390;
MNS5785, Lot Number 2023032290;
MNS5785, Lot Number 2023090590;
MNS5785, Lot Number 2023120790;
MNS5785, Lot Number 2024030690;
SUT4020, Lot Number 2020051990;
SUT4020, Lot Number 2020062490;
UVT125, Lot Number 2021082390;
MNS5460, Lot Number 2020051990;
UVT1080, Lot Number 2022121990;
UVT1080, Lot Number 2023090590;
UVT1100A, Lot Number 2022050280;
UVT1100A, Lot Number 2023011680;
UVT1100A, Lot Number 2023041780;
UVT1100A, Lot Number 2023061980;
UVT1100A, Lot Number 2023101680;
UVT1100A, Lot Number 2023120480;
UVT1100A, Lot Number 2024011580;
MNS11020A, Lot Number 2021060190
|
Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
|
| For Additional Information Contact | Karin Johnson
886-359-1704 |
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Manufacturer Reason
for Recall | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | Medline Industries LP issued a recall notice to its consignees on 04/08/2024 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request that the syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods. |
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| Distribution | worldwide |
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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 = LRO
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