| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | February 11, 2025 |
|---|
| Date Posted | March 25, 2025 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1448-2025 |
|---|
| Recall Event ID |
96374 |
| Product Classification |
Cesarean section tray - Product Code OHM
|
| Product | Medline procedure kits labeled as:
1) C SECTION, Pack Number DYNJ57622;
2) C SECTION PACK, Pack Number DYNJ48483B;
3) C SECTION PACK, Pack Number DYNJ61573;
4) C SECTION PACK, Pack Number DYNJ66801;
5) C SECTION PACK-LF, Pack Number DYNJ0367951P;
6) C SECTION PACK-LF, Pack Number DYNJ55345D;
7) C-SECTION PACK, Pack Number DYNJ04521J;
8) C-SECTION PACK, Pack Number DYNJ32632F;
9) C-SECTION PACK, Pack Number DYNJ65961B;
10) SMJ C-SECTION PACK-LF, Pack Number DYNJ38582J |
|---|
| Code Information |
1) Pack Number DYNJ57622: UDI/DI 10889942757244 (each) 40889942757245 (case), Lot Number 20LMF902A;
2) Pack Number DYNJ48483B: UDI/DI 10193489659405 (each) 40193489659406 (case), Lot Number 20CKB746A;
3) Pack Number DYNJ61573: UDI/DI 10193489601077 (each) 40193489601078 (case), Lot Number 22CMB584A;
4) Pack Number DYNJ66801: UDI/DI 10193489384000 (each) 40193489384001 (case), Lot Number 22GBW063A;
5) Pack Number DYNJ0367951P: UDI/DI 10193489966923 (each) 40193489966924 (case), Lot Number 21IMH644A;
6) Pack Number DYNJ55345D: UDI/DI 10195327173722 (each) 40195327173723 (case), Lot Number 22GBJ830A;
7) Pack Number DYNJ04521J: UDI/DI 10193489555837 (each) 40193489555838 (case), Lot Number 21HMA851A;
8) Pack Number DYNJ32632F: UDI/DI 10193489888966 (each) 40193489888967 (case), Lot Number 21IMD959A;
9) Pack Number DYNJ65961B: UDI/DI 10193489984309 (each) 40193489984300 (case), Lot Number 23LMG679A;
10) Pack Number DYNJ38582J: UDI/DI 10193489528244 (each) 40193489528245 (case), Lot Number 21IMF094A |
| 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 |
|---|
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. |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
|---|
| 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.
This is an expansion of RES 94583 |
|---|
| Quantity in Commerce | 605 units |
|---|
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
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.
|
|
|
|
