| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | September 04, 2024 |
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| Date Posted | October 23, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0179-2025 |
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| Recall Event ID |
95415 |
| Product Classification |
Orthopedic tray - Product Code OJH
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| Product | Medline brand medical procedure convenience kits, labeled as:
1) NEW LONDON TOTAL KNEE CDS, REF CDS982519W;
2) HAND/FOOT CDS, REF CDS984003A;
3) SPECIAL PROCEDURE PACK, REF DYNJ32639C;
4) PK-ORTHO-MINOR, REF DYNJ39547B;
5) ANT CERV ADD ON PACK, REF DYNJ41229C;
6) NAVIGATIONAL SPINE FUSION, REF DYNJ45153B;
7) FEET, ELBOW, AND ANKLE TEGH-LF, REF DYNJ46719B;
8) PLASTIC HAND PACK TEGH-LF, REF DYNJ46739B;
9) CVL INSERTION KIT-LF, REF DYNJ48587A;
10) CVL INSERTION KIT-LF, REF DYNJ48587A;
11) ENSEMBLE SURPLUS LCA-LF, REF DYNJ48892C;
12) EXTREMITY PACK, REF DYNJ49301B;
13) ACL ACCESSORY PACK, REF DYNJ50952F;
14) SPINAL INJECTION PACK, REF DYNJ51383F;
15) FTMC ARTHROS BASIC SETUP-LF, REF DYNJ54602A;
16) MINOR EXTREMITY PACK, REF DYNJ55324G;
17) MINOR EXTREMITY PACK, REF DYNJ55324G;
18) D-SPINE SUPPLEMENT PACK, REF DYNJ58115A;
19) EXTREMITY PACK, REF DYNJ62877;
20) AHT LG KNEE ROLL, REF DYNJ64823;
21) CUSTOM ORTHO PACK, REF DYNJ83675;
22) DR SUNDAR SCS KIT, REF DYNJ85288A;
23) CENTRAL SCS TRIAL PACK, REF DYNJ85503;
24) TOTAL KNEE CDS-LF, REF DYNJ909569;
25) EXTREMITY PACK, REF SYNJ10253B;
26) CARROLLTON HIP FX, REF SYNJ910003A;
27) ARTHROSCOPY, REF SYNJ910004C |
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| Code Information |
1) REF CDS982519W, UDI/DI 40195327389971 (each), 10195327389970 (case), Lot Numbers: 24BBQ775;
2) REF CDS984003A, UDI/DI 40888277002891 (each), 10888277002890 (case), Lot Numbers: 24ABG354;
3) REF DYNJ32639C, UDI/DI 40889942919223 (each), 10889942919222 (case), Lot Numbers: 23KBE944;
4) REF DYNJ39547B, UDI/DI 40193489760485 (each), 10193489760484 (case), Lot Numbers: 23LBO506;
5) REF DYNJ41229C, UDI/DI 40195327609727 (each), 10195327609726 (case), Lot Numbers: 24ABK563;
6) REF DYNJ45153B, UDI/DI 40195327235414 (each), 10195327235413 (case), Lot Numbers: 24ABD667;
7) REF DYNJ46719B, UDI/DI 40889942279303 (each), 10889942279302 (case), Lot Numbers: 23LBP194;
8) REF DYNJ46739B, UDI/DI 40889942314318 (each), 10889942314317 (case), Lot Numbers: 24ABG221;
9) REF DYNJ48587A, UDI/DI 40889942313106 (each), 10889942313105 (case), Lot Numbers: 23LBO732;
10) REF DYNJ48587A, UDI/DI 40889942313106 (each), 10889942313105 (case), Lot Numbers: 23KBO606;
11) REF DYNJ48892C, UDI/DI 40889942791768 (each), 10889942791767 (case), Lot Numbers: 23KBB893;
12) REF DYNJ49301B, UDI/DI 40889942686613 (each), 10889942686612 (case), Lot Numbers: 24ABB592;
13) REF DYNJ50952F, UDI/DI 40193489361668 (each), 10193489361667 (case), Lot Numbers: 23LBV189;
14) REF DYNJ51383F, UDI/DI 40193489225588 (each), 10193489225587 (case), Lot Numbers: 23LBS071;
15) REF DYNJ54602A, UDI/DI 40195327456673 (each), 10195327456672 (case), Lot Numbers: 23LBO084;
16) REF DYNJ55324G, UDI/DI 40195327433964 (each), 10195327433963 (case), Lot Numbers: 23LBL961;
17) REF DYNJ55324G, UDI/DI 40195327433964 (each), 10195327433963 (case), Lot Numbers: 23KBE137;
18) REF DYNJ58115A, UDI/DI 40195327582037 (each), 10195327582036 (case), Lot Numbers: 23LBL852;
19) REF DYNJ62877, UDI/DI 40193489695824 (each), 10193489695823 (case), Lot Numbers: 23LBV377;
20) REF DYNJ64823, UDI/DI 40193489221054 (each), 10193489221053 (case), Lot Numbers: 23LBK801;
21) REF DYNJ83675, UDI/DI 40195327296408 (each), 10195327296407 (case), Lot Numbers: 24ABG702;
22) REF DYNJ85288A, UDI/DI 40195327543083 (each), 10195327543082 (case), Lot Numbers: 24ABG603;
23) REF DYNJ85503, UDI/DI 40195327509904 (each), 10195327509903 (case), Lot Numbers: 23LBS030;
24) REF DYNJ909569, UDI/DI 40195327399703 (each), 10195327399702 (case), Lot Numbers: 24BBF009;
25) REF SYNJ10253B, UDI/DI 40193489373593 (each), 10193489373592 (case), Lot Numbers: 24ABG182;
26) REF SYNJ910003A, UDI/DI 40889942848448 (each), 10889942848447 (case), Lot Numbers: 24ABW931;
27) REF SYNJ910004C, UDI/DI 40195327246748 (each), 10195327246747 (case), Lot Numbers: 24BBC876
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Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
|
| For Additional Information Contact | Karin Johnson
866-359-1704 |
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Manufacturer Reason
for Recall | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 09/05/2024 via email and USPS. The notice explained the issue, hazard, and requested the destruction of the affected product. Distributors were directed to notify their consignees. |
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| Quantity in Commerce | 2371 units |
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| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Panama. |
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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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