| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | February 11, 2025 |
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| Date Posted | March 25, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1438-2025 |
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| Recall Event ID |
96374 |
| Product Classification |
Cardiovascular procedure kit - Product Code OEZ
|
| Product | Medline procedure kits labeled as:
1) AV FISTULA PACK, Pack Number DYNJ80088;
2) AV FISTULA PACK-LF, Pack Number DYNJ0131782J;
3) CABG, Pack Number DYNJ906462B;
4) CABG ACCESSORY PACK-LF, Pack Number DYNJ0261346U;
5) CARDIAC CATH PACEMAKER-LF, Pack Number DYNJ42997C;
6) CARDIAC CATH PACK, Pack Number DYNJ61256A;
7) CARDIAC CATH PACK-LF, Pack Number DYNJ61527;
8) CARDIAC CATH PACK-LF, Pack Number DYNJ53642C;
9) CARDIOVASCULAR PACK LJ-LF, Pack Number DYNJ49635F;
10) CAROTID PACK, Pack Number DYNJ0810062AI;
11) CASTRO CABG-COMPONENT PACK, Pack Number DYNJ44857T;
12) CATH PACK, Pack Number DYNJ59830A;
13) CHOG CARDIAC CATH PACK, Pack Number SYNJ10304B;
14) CICC, Pack Number DYNJ53854A;
15) CMHP PACEMAKER PACK, Pack Number DYNJ30217G;
16) DR NACKMAN VEIN PACK, Pack Number DYNJ56235;
17) ENDOVASCULAR AAA PACK-LF, Pack Number DYNJ55482F;
18) EP DEVICE, Pack Number DYNJ65916B;
19) EP STUDY PACK-LF, Pack Number DYNJ38059A;
20) FHZ PACEMAKER PACK, Pack Number DYNJ36931D;
21) GV OPEN HEART PACK, Pack Number DYNJ60618C;
22) HEART CABG CDS, Pack Number CDS983376Q;
23) HEART DRAPE & SUPPLY PACK, Pack Number DYNJ65226;
24) HH ARTERIOGRAM PACK, Pack Number DYNJ59466A;
25) LEX OPEN HEART, Pack Number DYNJ900968I;
26) MAJOR VASCULAR PACK SAFETY, Pack Number DYNJ54738C;
27) NIR PACK, Pack Number DYNJ63892A;
28) OPEN HEART, Pack Number DYNJ904261B;
29) OPEN HEART, Pack Number DYNJ904261B;
30) OPEN HEART, Pack Number DYNJ905021J;
31) OPEN HEART A PACK, Pack Number DYNJ04478R;
32) OPEN HEART ACC, Pack Number DYNJ23533D;
33) OPEN HEART CDS, Pack Number CDS840171AB;
34) OPEN HEART DRAPE PACK-LF, Pack Number DYNJ0382048N;
35) OPEN HEART PACK, Pack Number DYNJ45122C;
36) OPEN HEART PACK, Pack Number DYNJ55648;
37) OPEN HEART PACK, Pack Number DYNJ04381J;
38) OPEN HEART PACK & BASIN SET-LF, Pack Number DYNJ24300M;
39) OPEN HEART PACK-LF, Pack Number DYNJ0369758N;
40) OPEN HEART PART B PACK, Pack Number DYNJ43038N;
41) OPEN HEART SUPPLY, Pack Number DYNJ65641;
42) OPEN PACK, Pack Number DYNJ67442B;
43) PACEMAKER, Pack Number DYNJ59399I;
44) PACEMAKER IMPLANT PACK-LF, Pack Number DYNJ0373237M;
45) PACEMAKER PACK, Pack Number DYNJ66165;
46) PACEMAKER PACK, Pack Number DYNJ41134B;
47) PACEMAKER PACK, Pack Number DYNJ61260A;
48) PACEMAKER PACK, Pack Number DYNJ60635;
49) PACEMAKER PACK, Pack Number DYNJ42602C;
50) PACEMAKER PACK 0121271-LF, Pack Number DYNJ32897J;
51) PACEMAKER PACK CV-LF, Pack Number DYNJ39912B;
52) PACEMAKER PACK-LF, Pack Number DYNJ53112B;
53) PACEMAKER PACK-LF, Pack Number DYNJ51844B;
54) PACEMAKER PACK-LF, Pack Number DYNJ0854874R;
55) PEDI EP PACK, Pack Number DYNJ54750G;
56) PERMANENT PACING PACK-LF, Pack Number DYNJ22036F;
57) PK, OPEN HEART, Pack Number DYNJ44015B;
58) PK, OPEN HEART-CABG, Pack Number DYNJ45048C;
59) RR-ADULT PUMP PACK-LF, Pack Number DYNJ0394805N;
60) RRMC CAROTID PACK-2, Pack Number DYNJ33544L;
61) RR-PEDIATRIC PUMP PACK-LF, Pack Number DYNJ0394730P;
62) TAVR PACK, Pack Number DYNJ58386A;
63) THORACIC PACK, Pack Number DYNJ80309;
64) VASCULAR, Pack Number DYNJ45376G;
65) VASCULAR PACK, Pack Number DYNJ48288C;
66) VASCULAR PACK, Pack Number DYNJ54979;
67) VASCULAR PACK, Pack Number DYNJ64883C;
68) VASCULAR PACK, Pack Number DYNJ43945I;
69) VASCULAR PACK, Pack Number DYNJ43945I;
70) VASCULAR PACK, Pack Number DYNJ67426A;
71) VASCULAR PACK WRO-LF, Pack Number DYNJ41863C;
72) VASCULAR SUB, Pack Number DYNJ60681A;
73) VASCULAR SUB, Pack Number DYNJ60681A |
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| Code Information |
1) Pack Number DYNJ80088: UDI/DI 10195327010522 (each) 40195327010523 (case), Lot Number 23DBG477A;
2) Pack Number DYNJ0131782J: UDI/DI 10195327467548 (each) 40195327467549 (case), Lot Number 23LMD975A;
3) Pack Number DYNJ906462B: UDI/DI 10195327057886 (each) 40195327057887 (case), Lot Number 22GBV822Z;
4) Pack Number DYNJ0261346U: UDI/DI 10195327055967 (each) 40195327055968 (case), Lot Number 22GMB113A;
5) Pack Number DYNJ42997C: UDI/DI 10193489988420 (each) 40193489988421 (case), Lot Number 21JMG551A;
6) Pack Number DYNJ61256A: UDI/DI 10193489694918 (each) 40193489694919 (case), Lot Number 23JBH403A;
7) Pack Number DYNJ61527: UDI/DI 10193489578881 (each) 40193489578882 (case), Lot Number 21LBJ158A;
8) Pack Number DYNJ53642C: UDI/DI 10193489721607 (each) 40193489721608 (case), Lot Number 24AMF039A;
9) Pack Number DYNJ49635F: UDI/DI 10195327191405 (each) 40195327191406 (case), Lot Number 23LMF122A;
10) Pack Number DYNJ0810062AI: UDI/DI 10193489866049 (each) 40193489866040 (case), Lot Number 22CMB582A;
11) Pack Number DYNJ44857T: UDI/DI 10195327221959 (each) 40195327221950 (case), Lot Number 22JBD481Z;
12) Pack Number DYNJ59830A: UDI/DI 10193489570236 (each) 40193489570237 (case), Lot Number 21EMF434A;
13) Pack Number SYNJ10304B: UDI/DI 10193489786965 (each) 40193489786966 (case), Lot Number 21LBD584A;
14) Pack Number DYNJ53854A: UDI/DI 10193489631517 (each) 40193489631518 (case), Lot Number 21GMB561A;
15) Pack Number DYNJ30217G: UDI/DI 10193489922141 (each) 40193489922142 (case), Lot Number 23CBN679A;
16) Pack Number DYNJ56235: UDI/DI 10889942621552 (each) 40889942621553 (case), Lot Number 23EBD843A;
17) Pack Number DYNJ55482F: UDI/DI 10195327332273 (each) 40195327332274 (case), Lot Number 23BBS877A;
18) Pack Number DYNJ65916B: UDI/DI 10193489902044 (each) 40193489902045 (case), Lot Number 23JBT190A;
19) Pack Number DYNJ38059A: UDI/DI 10193489401110 (each) 40193489401111 (case), Lot Number 20LMF803A;
20) Pack Number DYNJ36931D: UDI/DI 10193489927559 (each) 40193489927550 (case), Lot Number 23BBS364Z;
21) Pack Number DYNJ60618C: UDI/DI 10193489475630 (each) 40193489475631 (case), Lot Number 22GMD148Z;
22) Pack Number CDS983376Q: UDI/DI 10195327379797 (each) 40195327379798 (case), Lot Number 23IBG370Z;
23) Pack Number DYNJ65226: UDI/DI 10193489253672 (each) 40193489253673 (case), Lot Number 20BDA909A;
24) Pack Number DYNJ59466A: UDI/DI 10193489562613 (each) 40193489562614 (case), Lot Number 21BBF996A;
25) Pack Number DYNJ900968I: UDI/DI 10193489453188 (each) 40193489453189 (case), Lot Number 22IBM300N;
26) Pack Number DYNJ54738C: UDI/DI 10193489778755 (each) 40193489778756 (case), Lot Number 21EBF317A;
27) Pack Number DYNJ63892A: UDI/DI 10195327176518 (each) 40195327176519 (case), Lot Number 23LME320A;
28) Pack Number DYNJ904261B: UDI/DI 10193489479539 (each) 40193489479530 (case), Lot Number 22IBN057Z;
29) Pack Number DYNJ904261B: UDI/DI 10193489479539 (each) 40193489479530 (case), Lot Number 22JBJ452Z;
30) Pack Number DYNJ905021J: UDI/DI 10195327281625 (each) 40195327281626 (case), Lot Number 23DBI088Z;
31) Pack Number DYNJ04478R: UDI/DI 10888277748835 (each) 40888277748836 (case), Lot Number 22GMA554A;
32) Pack Number DYNJ23533D: UDI/DI 10193489470659 (each) 40193489470650 (case), Lot Number 22GMC009A;
33) Pack Number CDS840171AB: UDI/DI 10195327167042 (each) 40195327167043 (case), Lot Number 22GMG011Z;
34) Pack Number DYNJ0382048N: UDI/DI 10195327537364 (each) 40195327537365 (case), Lot Number 23JBV598A;
35) Pack Number DYNJ45122C: UDI/DI 10193489496369 (each) 40193489496360 (case), Lot Number 21EME856A;
36) Pack Number DYNJ55648: UDI/DI 10889942581900 (each) 40889942581901 (case), Lot Number 21LBN735A;
37) Pack Number DYNJ04381J: UDI/DI 10888277745155 (each) 40888277745156 (case), Lot Number 23GMB245A;
38) Pack Number DYNJ24300M: UDI/DI 10193489823608 (each) 40193489823609 (case), Lot Number 23FBL428A;
39) Pack Number DYNJ0369758N: UDI/DI 10193489501247 (each) 40193489501248 (case), Lot Number 22GBO541Z;
40) Pack Number DYNJ43038N: UDI/DI 10195327263911 (each) 40195327263912 (case), Lot Number 23EMD464A;
41) Pack Number DYNJ65641: UDI/DI 10193489282986 (each) 40193489282987 (case), Lot Number 21BBF660A;
42) Pack Number DYNJ67442B: UDI/DI 10195327133542 (each) 40195327133543 (case), Lot Number 23DBR515A;
43) Pack Number DYNJ59399I: UDI/DI 10195327442071 (each) 40195327442072 (case), Lot Number 23HMB191A;
44) Pack Number DYNJ0373237M: UDI/DI 10193489369014 (each) 40193489369015 (case), Lot Number 23LBU493Z;
45) Pack Number DYNJ66165: UDI/DI 10193489319729 (each) 40193489319720 (case), Lot Number 20DBP548A;
46) Pack Number DYNJ41134B: UDI/DI 10889942011643 (each) 40889942011644 (case), Lot Number 21BBI489A;
47) Pack Number DYNJ61260A: UDI/DI 10193489857481 (each) 40193489857482 (case), Lot Number 21HMF542A;
48) Pack Number DYNJ60635: UDI/DI 10193489518153 (each) 40193489518154 (case), Lot Number 21IMG997A;
49) Pack Number DYNJ42602C: UDI/DI 10195327019198 (each) 40195327019199 (case), Lot Number 23BBR329A;
50) Pack Number DYNJ32897J: UDI/DI 10193489648102 (each) 40193489648103 (case), Lot Number 20AKB914A;
51) Pack Number DYNJ39912B: UDI/DI 10889942705078 (each) 40889942705079 (case), Lot Number 21GMA579A;
52) Pack Number DYNJ53112B: UDI/DI 10193489650617 (each) 40193489650618 (case), Lot Number 21IMF023A;
53) Pack Number DYNJ51844B: UDI/DI 10889942615773 (each) 40889942615774 (case), Lot Number 21LME446A;
54) Pack Number DYNJ0854874R: UDI/DI 10195327094966 (each) 40195327094967 (case), Lot Number 22CMB704A;
55) Pack Number DYNJ54750G: UDI/DI 10195327021351 (each) 40195327021352 (case), Lot Number 22GBH035A;
56) Pack Number DYNJ22036F: UDI/DI 10889942528899 (each) 40889942528890 (case), Lot Number 20FBH674A;
57) Pack Number DYNJ44015B: UDI/DI 10193489215939 (each) 40193489215930 (case), Lot Number 23EMD927A;
58) Pack Number DYNJ45048C: UDI/DI 10193489808889 (each) 40193489808880 (case), Lot Number 21IMD394A;
59) Pack Number DYNJ0394805N: UDI/DI 10193489245240 (each) 40193489245241 (case), Lot Number 23LME396A;
60) Pack Number DYNJ33544L: UDI/DI 10195327279318 (each) 40195327279319 (case), Lot Number 23LMF755A;
61) Pack Number DYNJ0394730P: UDI/DI 10193489430943 (each) 40193489430944 (case), Lot Number 21LMG091A;
62) Pack Number DYNJ58386A: UDI/DI 10193489397468 (each) 40193489397469 (case), Lot Number 21VBB871A;
63) Pack Number DYNJ80309: UDI/DI 10195327023218 (each) 40195327023219 (case), Lot Number 23LMF645A;
64) Pack Number DYNJ45376G: UDI/DI 10195327209353 (each) 40195327209354 (case), Lot Number 23KMD075A;
65) Pack Number DYNJ48288C: UDI/DI 10888277745599 (each) 40888277745590 (case), Lot Number 21IMH225A;
66) Pack Number DYNJ54979: UDI/DI 10889942519910 (each) 40889942519911 (case), Lot Number 21LBL535Z;
67) Pack Number DYNJ64883C: UDI/DI 10193489369670 (each) 40193489369671 (case), Lot Number 23BBR373A;
68) Pack Number DYNJ43945I: UDI/DI 10193489704242 (each) 40193489704243 (case), Lot Number 23GME703A;
69) Pack Number DYNJ43945I: UDI/DI 10193489704242 (each) 40193489704243 (case), Lot Number 23HMC425A;
70) Pack Number DYNJ67426A: UDI/DI 10195327049317 (each) 40195327049318 (case), Lot Number 23HMC554A;
71) Pack Number DYNJ41863C: UDI/DI 10195327463632 (each) 40195327463633 (case), Lot Number 23HBW577A;
72) Pack Number DYNJ60681A: UDI/DI 10193489780819 (each) 40193489780810 (case), Lot Number 20EBI994A;
73) Pack Number DYNJ60681A: UDI/DI 10193489780819 (each) 40193489780810 (case), Lot Number 21BBI579A |
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.
This is an expansion of RES 94583 |
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| Quantity in Commerce | 3860 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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