| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | February 11, 2025 |
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| Date Posted | March 26, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1461-2025 |
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| Recall Event ID |
96373 |
| Product Classification |
Ear, nose, and throat surgical tray - Product Code OGR
|
| Product | Medline procedure kits labeled as:
1) BILLINGS CLINIC SC HEAD & NECK, Pack Number DYNJ33656C;
2) BLEPH/RHINO PACK, Pack Number DYNJ64669A;
3) DB ENT CSTM PACK-LF, Pack Number DYNJ33585C;
4) DENTAL PACK, Pack Number DYNJ54064;
5) EAR PACK, Pack Number DYNJ68678C;
6) ENT HEAD NECK PACK, Pack Number DYNJ49023D;
7) ENT PACK, Pack Number DYNJ42564B;
8) ENT PACK, Pack Number DYNJ50572;
9) ENT PACK, Pack Number DYNJ45175B;
10) ENT PACK, Pack Number DYNJ65585A;
11) EP PACK, Pack Number DYNJ59171;
12) FUNCTIONAL ENDO SINUS WEILER, Pack Number DYNJ58857A;
13) HEAD & NECK, Pack Number DYNJ902987F;
14) HEAD & NECK PACK, Pack Number DYNJ61295B;
15) HEAD & NECK PACK, Pack Number DYNJ30234B;
16) HEAD & NECK PACK, Pack Number DYNJ50383;
17) HEAD & NECK PACK, Pack Number DYNJ36634K;
18) HEAD & NECK PACK, Pack Number DYNJ66399;
19) HEAD AND NECK PACK-LF, Pack Number DYNJ38402I;
20) MAJOR ENT HARPER PACK-LF, Pack Number DYNJ0161710I;
21) NASAL SINUS PACK-LF, Pack Number DYNJ0751486N;
22) NE NASAL, Pack Number DYNJ03130D;
23) ORL PACK, Pack Number DYNJ63705B;
24) SINUS PACK, Pack Number DYNJ50110B;
25) SINUS PACK, Pack Number DYNJ50110B;
26) T & A PACK, Pack Number DYNJ58811A;
27) THORACIC PACK, Pack Number DYNJ30731M;
28) THYROIDECTOMIE DIAGNOSTIQUE-LF, Pack Number DYNJ42678A;
29) TONSILS & ADENOIDS, Pack Number DYNJ69465;
30) TRANSPHENOIDAL PACK, Pack Number DYNJ46556B; |
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| Code Information |
1) Pack Number DYNJ55316G: UDI/DI 10889942278022 (each) 40889942278023 (case), Lot Number 20BDA583A;
2) Pack Number DYNJ37741B: UDI/DI 10193489682212 (each) 40193489682213 (case), Lot Number 20BDB113A;
3) Pack Number DYNJ0809731F: UDI/DI 10193489369892 (each) 40193489369893 (case), Lot Number 20FBS559A;
4) Pack Number DYNJ66665: UDI/DI 10888277546394 (each) 40888277546395 (case), Lot Number 20FMA565A;
5) Pack Number DYNJ37707D: UDI/DI 10193489258936 (each) 40193489258937 (case), Lot Number 20HKB321A;
6) Pack Number DYNJ64526A: UDI/DI 10193489531589 (each) 40193489531580 (case), Lot Number 20HMC644A;
7) Pack Number DYNJ62755B: UDI/DI 10193489296792 (each) 40193489296793 (case), Lot Number 20HMD066A;
8) Pack Number DYNJ61634B: UDI/DI 10888277756168 (each) 40888277756169 (case), Lot Number 20HMD167A;
9) Pack Number DYNJ83129: UDI/DI 10193489366815 (each) 40193489366816 (case), Lot Number 20JKA848A;
10) Pack Number DYNJ35906F: UDI/DI 10193489718577 (each) 40193489718578 (case), Lot Number 20LBI228Z;
11) Pack Number DYNJ35906F: UDI/DI 10193489397598 (each) 40193489397599 (case), Lot Number 20LBS935Z;
12) Pack Number DYNJCEN04C: UDI/DI 10193489805413 (each) 40193489805414 (case), Lot Number 21BBI544A;
13) Pack Number DYNJ54684B: UDI/DI 10193489551068 (each) 40193489551069 (case), Lot Number 21IMD870A;
14) Pack Number DYNJ44692D: UDI/DI 10193489909869 (each) 40193489909860 (case), Lot Number 21IME024A;
15) Pack Number DYNJ0190688Q: UDI/DI 10193489322644 (each) 40193489322645 (case), Lot Number 21IME395A;
16) Pack Number DYNJ64670B: UDI/DI 10889942575701 (each) 40889942575702 (case), Lot Number 21IME484A;
17) Pack Number DYNJ30196F: UDI/DI 10193489976625 (each) 40193489976626 (case), Lot Number 21IME728A;
18) Pack Number DYNJ51796G: UDI/DI 10889942651887 (each) 40889942651888 (case), Lot Number 21IME769A;
19) Pack Number DYNJ39734D: UDI/DI 10193489303940 (each) 40193489303941 (case), Lot Number 21IMH101A;
20) Pack Number DYNJ64208: UDI/DI 10193489917703 (each) 40193489917704 (case), Lot Number 22FBW094A;
21) Pack Number DYNJ43522C: UDI/DI 10195327176310 (each) 40195327176311 (case), Lot Number 22GBL783M;
22) Pack Number DYNJ59765A: UDI/DI 10195327155780 (each) 40195327155781 (case), Lot Number 22GBM456Z;
23) Pack Number DYNJ54965: UDI/DI 10889942275069 (each) 40889942275060 (case), Lot Number 22GMA060Z;
24) Pack Number DYNJ09866U: UDI/DI 10195327230081 (each) 40195327230082 (case), Lot Number 22JBY434A;
25) Pack Number DYNJ45861B: UDI/DI 10193489276510 (each) 40193489276511 (case), Lot Number 22KBC920Z;
26) Pack Number DYNJ27165V: UDI/DI 10888277208872 (each) 40888277208873 (case), Lot Number 23CBN716A;
27) Pack Number DYNJ35449G: UDI/DI 10195327040239 (each) 40195327040230 (case), Lot Number 23CBO497A;
28) Pack Number DYNJ62673A: UDI/DI 10195327026592 (each) 40195327026593 (case), Lot Number 23CDC561A;
29) Pack Number DYNJ37636L: UDI/DI 10195327299064 (each) 40195327299065 (case), Lot Number 23CLA003A;
30) Pack Number DYNJ24637J: UDI/DI 10195327383596 (each) 40195327383597 (case), Lot Number 23GMC950A
|
| FEI Number |
1417592
|
Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
|
| For Additional Information Contact | Haley Barclay
866-359-1704 |
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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 02/11/2025 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 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.
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| Quantity in Commerce | 2161 kits |
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| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
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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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