| | 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-1462-2025 |
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| Recall Event ID |
96373 |
| Product Classification |
Plastic surgery and accessories kit - Product Code FTN
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| Product | Medline procedure kits labeled as:
1) BREAST PACK-LF, Pack Number DYNJ0956628O;
2) BREAST SURGERY FOAKS, Pack Number DYNJ63577C;
3) CHEST BREAST -LF, Pack Number DYNJCEN04C;
4) DIEP PACK, Pack Number DYNJ60669G;
5) FACE LIFT PACK, Pack Number DYNJ64670B;
6) FREE FLAP A PACK, Pack Number DYNJ40647G;
7) IPMC BREAST PACK-LF, Pack Number DYNJ0665560D;
8) OCULAR PLASTICS PACK, Pack Number DYNJ40356A;
9) OCULOPLASTY PACK-LF, Pack Number DYNJ0252232U;
10) PACK MASTECTOMY COMBO CHRG, Pack Number DYNJ60232A;
11) PLASTIC GENERAL SURGERY - OSC, Pack Number DYNJ43576A;
12) PLASTIC PACK, Pack Number DYNJ00264L;
13) PLASTIC PACK, Pack Number DYNJ49742B;
14) PLASTIC PK II, Pack Number DYNJ14039B;
15) PLASTIC-GENERAL SURGERY PACK, Pack Number DYNJ09866U;
16) PLASTICS FACIAL PACK ST MARY, Pack Number DYNJ45861B;
17) PLASTICS PACK, Pack Number DYNJ68288A |
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| Code Information |
1) Pack Number DYNJ0956628O: UDI/DI 10193489785869 (each) 40193489785860 (case), Lot Number 21BBH575A;
2) Pack Number DYNJ63577C: UDI/DI 10193489267143 (each) 40193489267144 (case), Lot Number 21BBI089A;
3) Pack Number DYNJCEN04C: UDI/DI 10193489805413 (each) 40193489805414 (case), Lot Number 21BBI544A;
4) Pack Number DYNJ60669G: UDI/DI 10889942794942 (each) 40889942794943 (case), Lot Number 21EME131A;
5) Pack Number DYNJ64670B: UDI/DI 10889942575701 (each) 40889942575702 (case), Lot Number 21IME484A;
6) Pack Number DYNJ40647G: UDI/DI 10193489270976 (each) 40193489270977 (case), Lot Number 21IMH836A;
7) Pack Number DYNJ0665560D: UDI/DI 10195327089795 (each) 40195327089796 (case), Lot Number 22CMB464A;
8) Pack Number DYNJ40356A: UDI/DI 10193489228335 (each) 40193489228336 (case), Lot Number 22JBF484Z;
9) Pack Number DYNJ0252232U: UDI/DI 10195327217334 (each) 40195327217335 (case), Lot Number 22JBG465Z;
10) Pack Number DYNJ60232A: UDI/DI 10195327222451 (each) 40195327222452 (case), Lot Number 22JBN921Z;
11) Pack Number DYNJ43576A: UDI/DI 10193489920116 (each) 40193489920117 (case), Lot Number 22JBU153Z;
12) Pack Number DYNJ00264L: UDI/DI 10193489801866 (each) 40193489801867 (case), Lot Number 22JBU265A;
13) Pack Number DYNJ49742B: UDI/DI 10195327210267 (each) 40195327210268 (case), Lot Number 22JBV346A;
14) Pack Number DYNJ14039B: UDI/DI 10193489324495 (each) 40193489324496 (case), Lot Number 22JBW642A;
15) Pack Number DYNJ09866U: UDI/DI 10195327230081 (each) 40195327230082 (case), Lot Number 22JBY434A;
16) Pack Number DYNJ45861B: UDI/DI 10193489276510 (each) 40193489276511 (case), Lot Number 22KBC920Z;
17) Pack Number DYNJ68288A: UDI/DI 10193489276510 (each) 40193489276511 (case), Lot Number 22KBC927Z
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| FEI Number |
1417592
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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 | 1228 units |
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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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