| | 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-2776-2024 |
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| Recall Event ID |
94586 |
| Product Classification |
Tray, surgical - Product Code LRP
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| Product | Centurion procedure packs, containing Caina syringes, labeled as:
1) ARTHROGRAM, Pack Number DYNDH1446A;
2) ARTHROGRAM TRAY, Pack Number MNS11965A;
3) ARTHROGRAPH TRAY, Pack Number MNS12670A;
4) BREAST BIOPSY KIT, Pack Number DYNDH1512;
5) CIRCUMCISION KIT, Pack Number CIT6535;
6) CIRCUMCISION KIT, Pack Number CIT7095;
7) CIRCUMCISION TRAY, Pack Number CIT7020;
8) CIRCUMCISION TRAY, Pack Number CIT6720;
9) CIRCUMCISION TRAY, Pack Number CIT6715;
10) CIRCUMCISION TRAY, Pack Number CIT7210;
11) CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6925;
12) DISPOSABLE NICU UMBILICAL INSERTION TRAY, Pack Number UVT1030;
13) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780;
14) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920;
15) NURSERY CIRCUMCISION TRAY, Pack Number CIT4845;
16) PUNCH BIOPSY KIT, Pack Number MNS8245;
17) RETINAL INJECTION KIT, Pack Number MNS12465;
18) STERILE 1CC SYR W/ 27GX1/2 NDL, Pack Number DYNDA2496 |
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| Code Information |
DYNDH1446A, Lot Number 2020102990;
MNS11965A, Lot Number 2021061190;
MNS11965A, Lot Number 2021072690;
MNS11965A, Lot Number 2021083090;
MNS11965A, Lot Number 2022041390;
MNS11965A, Lot Number 2022091490;
MNS11965A, Lot Number 2023041090;
MNS12670A, Lot Number 2023060290;
DYNDH1512, Lot Number 2021100490;
CIT7095, Lot Number 2021061190;
CIT6535, Lot Number 2024031880;
CIT7020, Lot Number 2021120990;
CIT6720, Lot Number 2022032290;
CIT6715, Lot Number 2022062290;
CIT7210, Lot Number 2022071990;
CIT7020, Lot Number 2022091490;
CIT7210, Lot Number 2022120590;
CIT6715, Lot Number 2023012490;
CIT7020, Lot Number 2023030290;
CIT7210, Lot Number 2023030990;
CIT7210, Lot Number 2023060290;
CIT6925, Lot Number 2021081190;
CIT6925, Lot Number 2021090290;
CIT6925, Lot Number 2022070590;
UVT1030, Lot Number 2021072190;
UVT1030, Lot Number 2022032290;
CIT6780, Lot Number 2021081650;
CIT6780, Lot Number 2023092290;
CIT6920, Lot Number 2024020290;
CIT4845, Lot Number 2023042090;
CIT4845, Lot Number 2023070390;
CIT4845, Lot Number 2023081090;
MNS8245, Lot Number 2022111890;
MNS12465, Lot Number 2022072290;
MNS12465, Lot Number 2022111890;
MNS12465, Lot Number 2023042890;
MNS12465, Lot Number 2023102390;
MNS12465, Lot Number 2024022190;
MNS12465, Lot Number 2024030790;
MNS12465, Lot Number 2022022880;
DYNDA2496, Lot Number 2023102590 |
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 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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