| | 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-2772-2024 |
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| Recall Event ID |
94585 |
| Product Classification |
Labor and Delivery Kit - Product Code MLS
|
| Product | Centurion procedure kits, labeled as:
1) ARTHROGRAM TRAY, Pack Number DYNDH1349;
2) ARTHROGRAM TRAY-LF, Pack Number SPEC0400;
3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220;
4) BIOPSY KIT, Pack Number DYNDH1570;
5) BIOPSY TRAY-LF, Pack Number SPEC4380;
6) BMA BX TRAY, Pack Number DYNDH1050A;
7) BREAST BIOPSY TRAY, Pack Number SPEC0130C;
8) CATHETER ON/OFF KIT, Pack Number DT5490B;
9) CDP, INTRODUCER KIT 9F, Pack Number S5078BF09;
10) CHEST TUBE INSERTION TRAY, Pack Number CHT705;
11) CIRCUMCISION TRAY, Pack Number CIT6260;
12) CUSTOM BIOPSY TRAY, Pack Number MNS4815;
13) DELIVERY ACCESSORY KIT, Pack Number MNS6496;
14) DELIVERY PACK, Pack Number MNS2925A;
15) DELIVERY PACK, Pack Number MNS2925B;
16) E. R. LACERATION TRAY, Pack Number DYNDL1187A;
17) FINE LACERATION KIT, Pack Number SUT19360;
18) GENERAL BIOPSY TRAY- LF, Pack Number SPEC0248B;
19) GENERAL UTILITY, Pack Number DYNDA2524;
20) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227A;
21) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227B;
22) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150;
23) LACERATION TRAY, Pack Number DYNDL1757;
24) MYELOGRAM TRAY, Pack Number DYNDH1531;
25) OB DELIVERY SET, Pack Number MNS3355;
26) OB DELIVERY TRAY, Pack Number MNS10875;
27) OB DELIVERY TRAY, Pack Number MNS5575;
28) OB DELIVERY TRAY, Pack Number MNS10875A;
29) PICU LINE TRAY, Pack Number DYNDC1960A;
30) PORT ACCESS KIT, Pack Number DYNDC2945;
31) PORT ACCESS TRAY, Pack Number EBSI1241;
32) SINGLE TAP BLOCK TRAY, Pack Number SPEC0156A;
33) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A;
34) SUTURING SET, Pack Number SUT9790;
35) SUTURING SET, Pack Number SUT4020;
36) TRAY,GENERAL UTILITY, Pack Number DYNDL1422A;
37) U.A.C. TRAY, Pack Number UVT125;
38) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580;
39) VAGINAL DELIVERY TRAY, Pack Number MNS11020;
40) VAGINAL DELIVERY TRAY, Pack Number MNS11020A |
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| Code Information |
DYNDH1349, Lot Number 2019061090;
SPEC0400, Lot Number 2022010790;
SPEC0400, Lot Number 2022061490;
PT220, Lot Number 2020090390;
DYNDH1570, Lot Number 2023091390;
SPEC4380, Lot Number 2023110890;
DYNDH1050A, Lot Number 2019100490;
SPEC0130C, Lot Number 2020072090;
DT5490B, Lot Number 2022091590;
S5078BF09, Lot Number 2022122390;
CHT705, Lot Number 2021072990;
CIT6260, Lot Number 2022031190;
MNS4815, Lot Number 2022042890;
MNS6496, Lot Number 2018112690;
MNS6496, Lot Number 2019061390;
MNS6496, Lot Number 2020040190;
MNS6496, Lot Number 2020062290;
MNS6496, Lot Number 2020090290;
MNS6496, Lot Number 2021072990;
MNS6496, Lot Number 2022010790;
MNS6496, Lot Number 2022080890;
MNS6496, Lot Number 2022122390;
MNS6496, Lot Number 2023040690;
MNS2925A, Lot Number 2019080690;
MNS2925A, Lot Number 2019101190;
MNS2925B, Lot Number 2020032090;
MNS2925B, Lot Number 2020071690;
DYNDL1187A, Lot Number 2019080590;
DYNDL1187A, Lot Number 2019100490;
SUT19360, Lot Number 2023021090;
SPEC0248B, Lot Number 2019041790;
DYNDA2524, Lot Number 2019100490;
DYNDH1227A, Lot Number 2019061090;
DYNDH1227B, Lot Number 2019100490;
MNS12150, Lot Number 2021072990;
MNS12150, Lot Number 2022031190;
DYNDL1757, Lot Number 2019061090;
DYNDH1531, Lot Number 2023021090;
MNS3355, Lot Number 2019080590;
MNS3355, Lot Number 2019100490;
MNS3355, Lot Number 2020050890;
MNS3355, Lot Number 2020091090;
MNS3355, Lot Number 2020113090;
MNS3355, Lot Number 2021030890;
MNS3355, Lot Number 2021040990;
MNS3355, Lot Number 2021052890;
MNS3355, Lot Number 2021071590;
MNS3355, Lot Number 2021080990;
MNS3355, Lot Number 2021122390;
MNS3355, Lot Number 2022030790;
MNS3355, Lot Number 2022071590;
MNS3355, Lot Number 2022080590;
MNS3355, Lot Number 2022101490;
MNS3355, Lot Number 2023021090;
MNS3355, Lot Number 2023053090;
MNS3355, Lot Number 2023091390;
MNS3355, Lot Number 2023121490;
MNS10875, Lot Number 2019031590;
MNS5575, Lot Number 2019061090;
MNS5575, Lot Number 2020072090;
MNS5575, Lot Number 2020081790;
MNS10875A, Lot Number 2020081790;
MNS10875A, Lot Number 2020090390;
MNS5575, Lot Number 2020102390;
MNS5575, Lot Number 2021012590;
MNS10875A, Lot Number 2021012690;
MNS10875A, Lot Number 2021031190;
MNS10875A, Lot Number 2021051490;
MNS10875A, Lot Number 2021072990;
MNS10875A, Lot Number 2021102890;
MNS10875A, Lot Number 2022031190;
MNS10875A, Lot Number 2022061490;
MNS10875A, Lot Number 2022091590;
MNS10875A, Lot Number 2023040690;
MNS10875A, Lot Number 2023092990;
MNS10875A, Lot Number 2023110890;
DYNDC1960A, Lot Number 2022010790;
DYNDC2945, Lot Number 2023040690;
EBSI1241, Lot Number 2021021190;
SPEC0156A, Lot Number 2019100490;
DYNDC2859A, Lot Number 2020081790;
DYNDC2859A, Lot Number 2023053090;
SUT9790, Lot Number 2020090390;
SUT9790, Lot Number 2020113090;
SUT4020, Lot Number 2021051490;
SUT4020, Lot Number 2021072990;
SUT4020, Lot Number 2022071590;
DYNDL1422A, Lot Number 2019061090;
UVT125, Lot Number 2023110890;
MNS9580, Lot Number 2019100490;
MNS9580, Lot Number 2022042890;
MNS11020, Lot Number 2018103190;
MNS11020, Lot Number 2019012390;
MNS11020, Lot Number 2019041790;
MNS11020A, Lot Number 2019080690;
MNS11020A, Lot Number 2021021190;
MNS11020A, Lot Number 2021030390;
MNS11020A, Lot Number 2021041690;
MNS11020A, Lot Number 2022042890 |
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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