| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | April 08, 2024 |
|---|
| Date Posted | September 06, 2024 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-3009-2024 |
|---|
| Recall Event ID |
94583 |
| Product Classification |
Endoscope introducer kit - Product Code NWU
|
| Product | Medline Convenience kits labeled as:
1) GYN ENDOSCOPY KIT , Pack Number CDS981309O ;
2) GB GENERAL ENDO , Pack Number CDS984155F ;
3) ENDOSCOPY KIT , Pack Number DYKE1112 ;
4) ENDOSCOPY KIT , Pack Number DYKE1133A;
5) ENDOSCOPY PACK, Pack Number DYKE1264 ;
6) ENDOSCOPY KIT , Pack Number DYKE1389 ;
7) ENDO KIT, Pack Number DYKE1856 ;
8) WCH ENDO KIT, Pack Number DYKE1864B;
9) ENDO PACK , Pack Number DYNDA3058;
10) ENDOSCOPY PACK-LF , Pack Number DYNJ00339J ;
11) TR-ENT ENDO PACK-LF , Pack Number DYNJ0396027I ;
12) ENDOSCOPIC CHOLE PACK-LF, Pack Number DYNJ0426277J ;
13) GENERAL ENDOSCOPIC PACK-LF, Pack Number DYNJ22661L ;
14) GENERAL ENDOSCOPIC PACK-LF, Pack Number DYNJ22661O ;
15) ENDOSCOPY-LF, Pack Number DYNJ22890L ;
16) GENERAL ENDOSCOPY PACK, Pack Number DYNJ44673G ;
17) ENDOSCOPY PACK, Pack Number DYNJ50594C ;
18) ABD ENDOSCOPIC PACK , Pack Number DYNJ54221B ;
19) ABD ENDOSCOPIC PACK , Pack Number DYNJ54221C ;
20) ENDOSCOPIC PACK , Pack Number DYNJ54221J ;
21) CUSTOM ENDOSCOPY PACK-LF, Pack Number DYNJ55478B ;
22) CUSTOM ENDOSCOPY PACK-LF, Pack Number DYNJ55478D ;
23) ENDO PACK , Pack Number DYNJ56043B ;
24) ENDO PACK , Pack Number DYNJ56043C ;
25) ENDO PACK, Pack Number DYNJ56043F;
26) ENDO PACK , Pack Number DYNJ56043F ;
27) ENDOSCOPIC SKULL BASE , Pack Number DYNJ58648B ;
28) ENDOSCOPIC SKULL BASE , Pack Number DYNJ58648C ;
29) ENDOSCOPIC SKULL BASE , Pack Number DYNJ58648D ;
30) ENDOSCOPIC SKULL BASE , Pack Number DYNJ58648J ;
31) ENDO / AUG PACK , Pack Number DYNJ59250A ;
32) ENDO / AUG PACK , Pack Number DYNJ59250B ;
33) PACK ENDO AAA HYBRIDCHRG, Pack Number DYNJ60126B ;
34) DIPASCO GENERAL ENDOCRINE PACK, Pack Number DYNJ60686A ;
35) ENDOSCOPIC PACK , Pack Number DYNJ63797;
36) ENDOSCOPY PACK, Pack Number DYNJ65524;
37) GENERAL ENDOSCOPIC PK , Pack Number DYNJ66034A ;
38) ENT ENDO SINUS WILMINGTON PACK, Pack Number DYNJ66447;
39) ENDOVENOUS PACK , Pack Number DYNJ66596;
40) GENERAL ENDOSCOPIC PACK , Pack Number DYNJ67382B ;
41) PEDI ENDO LAP PACK, Pack Number DYNJ68141;
42) GEN ENDOSCOPY , Pack Number DYNJ81490;
43) PACK ENDOSCOPIC CHOLECYSTE, Pack Number DYNJ81539;
44) ENDO UROLOGY, Pack Number DYNJ83704A ;
45) ENDOSCOPY , Pack Number DYNJ900509N;
46) ENDOSCOPY , Pack Number DYNJ900509O;
47) ENDO OMH, Pack Number DYNJ900525C;
48) MODULE ENDO LAP , Pack Number DYNJ903026F;
49) MODULE ENDO LAP , Pack Number DYNJ903026G;
50) GENERAL ENDOSCOPY , Pack Number DYNJ903421D;
51) CYSTO , Pack Number DYNJ903521A;
52) GENERAL ENDOSCOPY , Pack Number DYNJ903826F;
53) ENDO, Pack Number DYNJ904836A;
54) ENDO, Pack Number DYNJ904836B;
55) ENDO, Pack Number DYNJ904836C;
56) ENDO, Pack Number DYNJ904836D;
57) DIPASCO GENERAL ENDOCRINE , Pack Number DYNJ906574 ;
58) ENDOSCOPIC SKULL BASE , Pack Number DYNJ908362B;
59) ENDOSCOPY KIT , Pack Number P830355A ;
60) ENDOSCOPY KIT , Pack Number P830355AH |
|---|
| Code Information |
CDS981309O , Lot Number 19GBS426 ;
CDS981309O , Lot Number 19JBE731 ;
CDS981309O , Lot Number 19LBN327 ;
CDS981309O , Lot Number 20BBE553 ;
CDS981309O , Lot Number 20DBG947 ;
CDS981309O , Lot Number 20GBU396 ;
CDS984155F , Lot Number 19GBV870 ;
CDS984155F , Lot Number 19JBX096 ;
DYKE1112 , Lot Number 23LME611 ;
DYKE1133A, Lot Number 22AMA243 ;
DYKE1264 , Lot Number 22GME430 ;
DYKE1264 , Lot Number 22HMA299 ;
DYKE1389 , Lot Number 19DBL730 ;
DYKE1389 , Lot Number 19DBN769 ;
DYKE1389 , Lot Number 19VBA308 ;
DYKE1389 , Lot Number 19KBI635 ;
DYKE1389 , Lot Number 20ABU603 ;
DYKE1856 , Lot Number 22JBU738 ;
DYKE1856 , Lot Number 22LBC945 ;
DYKE1856 , Lot Number 23ABJ226 ;
DYKE1864B, Lot Number 23LBG919 ;
DYNDA3058, Lot Number 23GBJ275 ;
DYNDA3058, Lot Number 23JBJ971 ;
DYNDA3058, Lot Number 23LBA980 ;
DYNJ00339J , Lot Number 19LMB920 ;
DYNJ00339J , Lot Number 20BMA093 ;
DYNJ00339J , Lot Number 19DKA281 ;
DYNJ00339J , Lot Number 19DKC903 ;
DYNJ00339J , Lot Number 19GKA519 ;
DYNJ00339J , Lot Number 19JKB148 ;
DYNJ0396027I , Lot Number 19DDA509 ;
DYNJ0426277J , Lot Number 19IMB754 ;
DYNJ0426277J , Lot Number 20AMA124 ;
DYNJ0426277J , Lot Number 20CMC692 ;
DYNJ0426277J , Lot Number 20FMB816 ;
DYNJ0426277J , Lot Number 20HMB568 ;
DYNJ0426277J , Lot Number 20IMD473 ;
DYNJ0426277J , Lot Number 21AMB951 ;
DYNJ0426277J , Lot Number 21CMC718 ;
DYNJ0426277J , Lot Number 21FMB061 ;
DYNJ0426277J , Lot Number 19HKC356 ;
DYNJ22661L , Lot Number 19HBO860 ;
DYNJ22661L , Lot Number 19IBM436 ;
DYNJ22661L , Lot Number 19JBQ066 ;
DYNJ22661L , Lot Number 19KBK813 ;
DYNJ22661L , Lot Number 19LBU575 ;
DYNJ22661L , Lot Number 20BBX496 ;
DYNJ22661L , Lot Number 20DBB020 ;
DYNJ22661L , Lot Number 20GMC054 ;
DYNJ22661L , Lot Number 20IMA806 ;
DYNJ22661L , Lot Number 20IMC442 ;
DYNJ22661L , Lot Number 20KMA517 ;
DYNJ22661L , Lot Number 20LMF851 ;
DYNJ22661L , Lot Number 21CMC664 ;
DYNJ22661L , Lot Number 21HMA104 ;
DYNJ22661L , Lot Number 21HMD574 ;
DYNJ22661L , Lot Number 21IME853 ;
DYNJ22661O , Lot Number 23GMB192 ;
DYNJ22661O , Lot Number 23HMD182 ;
DYNJ22661O , Lot Number 23IMG591 ;
DYNJ22890L , Lot Number 19DBH535 ;
DYNJ22890L , Lot Number 19EBT736 ;
DYNJ22890L , Lot Number 19FBX264 ;
DYNJ44673G , Lot Number 22IDB664 ;
DYNJ44673G , Lot Number 22JDB619 ;
DYNJ44673G , Lot Number 22KDB136 ;
DYNJ44673G , Lot Number 22KDC145 ;
DYNJ44673G , Lot Number 22LDA396 ;
DYNJ44673G , Lot Number 23CDC115 ;
DYNJ44673G , Lot Number 23DDB896 ;
DYNJ44673G , Lot Number 23EDB560 ;
DYNJ44673G , Lot Number 23GDB181 ;
DYNJ44673G , Lot Number 23KDA313 ;
DYNJ44673G , Lot Number 24ADA583 ;
DYNJ44673G , Lot Number 24ADB767 ;
DYNJ44673G , Lot Number 24BDB676 ;
DYNJ50594C , Lot Number 19IBX922 ;
DYNJ50594C , Lot Number 19JBY497 ;
DYNJ50594C , Lot Number 20CBA891 ;
DYNJ50594C , Lot Number 20DBQ243 ;
DYNJ50594C , Lot Number 20EBR005 ;
DYNJ50594C , Lot Number 20HBB011 ;
DYNJ50594C , Lot Number 20HBM366 ;
DYNJ50594C , Lot Number 21ABG167 ;
DYNJ50594C , Lot Number 21BBN822 ;
DYNJ50594C , Lot Number 21CBE742 ;
DYNJ54221B , Lot Number 19RBA244 ;
DYNJ54221B , Lot Number 19GBS216 ;
DYNJ54221B , Lot Number 19HBJ331 ;
DYNJ54221B , Lot Number 19HBL555 ;
DYNJ54221C , Lot Number 19JBQ044 ;
DYNJ54221C , Lot Number 19KBB653 ;
DYNJ54221C , Lot Number 19LBS870 ;
DYNJ54221C , Lot Number 20ABU331 ;
DYNJ54221C , Lot Number 20BBL702 ;
DYNJ54221C , Lot Number 20EBE847 ;
DYNJ54221C , Lot Number 20EBK160 ;
DYNJ54221J , Lot Number 23HBL781 ;
DYNJ54221J , Lot Number 23JBW829 ;
DYNJ54221J , Lot Number 23LBF338 ;
DYNJ55478B , Lot Number 21GBP757 ;
DYNJ55478B , Lot Number 21JBO286 ;
DYNJ55478B , Lot Number 21JBO302 ;
DYNJ55478B , Lot Number 21LBD900 ;
DYNJ55478B , Lot Number 21LBS328 ;
DYNJ55478B , Lot Number 22ABL817 ;
DYNJ55478B , Lot Number 22ABU347 ;
DYNJ55478B , Lot Number 19ABF658 ;
DYNJ55478B , Lot Number 22BBT857 ;
DYNJ55478B , Lot Number 19BBS313 ;
DYNJ55478B , Lot Number 22OBG299 ;
DYNJ55478B , Lot Number 22OBJ730 ;
DYNJ55478B , Lot Number 22EBL784 ;
DYNJ55478B , Lot Number 19EBA365 ;
DYNJ55478B , Lot Number 19GBH857 ;
DYNJ55478B , Lot Number 19HBL661 ;
DYNJ55478B , Lot Number 19JBX017 ;
DYNJ55478B , Lot Number 19LBG025 ;
DYNJ55478B , Lot Number 20CBE081 ;
DYNJ55478B , Lot Number 20CBM750 ;
DYNJ55478B , Lot Number 20DBQ209 ;
DYNJ55478B , Lot Number 20EBO179 ;
DYNJ55478B , Lot Number 21EBP478 ;
DYNJ55478B , Lot Number 21EBP489 ;
DYNJ55478D , Lot Number 23DBH240 ;
DYNJ55478D , Lot Number 23FBQ176 ;
DYNJ55478D , Lot Number 23HBE122 ;
DYNJ55478D , Lot Number 23IBT533 ;
DYNJ55478D , Lot Number 23KBW864 ;
DYNJ56043B , Lot Number 19FBW687 ;
DYNJ56043B , Lot Number 19RBC753 ;
DYNJ56043B , Lot Number 19HBD919 ;
DYNJ56043C , Lot Number 19UBA723 ;
DYNJ56043C , Lot Number 19KBS706 ;
DYNJ56043C , Lot Number 19LBN154 ;
DYNJ56043C , Lot Number 20BBR424 ;
DYNJ56043C , Lot Number 20CBG391 ;
DYNJ56043C , Lot Number 20EBH068 ;
DYNJ56043C , Lot Number 20FBN679 ;
DYNJ56043C , Lot Number 20HBB551 ;
DYNJ56043C , Lot Number 20JBN241 ;
DYNJ56043C , Lot Number 20KBK445 ;
DYNJ56043F, Lot Number 24BMB676;
DYNJ56043F , Lot Number 23JMA380 ;
DYNJ56043F , Lot Number 23LMA604 ;
DYNJ58648B , Lot Number 19BDB193 ;
DYNJ58648C , Lot Number 19EDD585 ;
DYNJ58648C , Lot Number 19IDA770 ;
DYNJ58648C , Lot Number 20AMA033 ;
DYNJ58648C , Lot Number 20AMC750 ;
DYNJ58648C , Lot Number 20EMB449 ;
DYNJ58648D , Lot Number 20KMC595 ;
DYNJ58648D , Lot Number 21AMB129 ;
DYNJ58648J , Lot Number 22KMD675 ;
DYNJ58648J , Lot Number 23DMD129 ;
DYNJ58648J , Lot Number 23HMG766 ;
DYNJ58648J , Lot Number 23JMD938 ;
DYNJ59250A , Lot Number 19IBG556 ;
DYNJ59250A , Lot Number 19JBB091 ;
DYNJ59250B , Lot Number 20ABS111 ;
DYNJ59250B , Lot Number 20EBR009 ;
DYNJ59250B , Lot Number 20FBA296 ;
DYNJ59250B , Lot Number 20GMD049 ;
DYNJ59250B , Lot Number 20HMD501 ;
DYNJ59250B , Lot Number 20IMC499 ;
DYNJ59250B , Lot Number 20JMD902 ;
DYNJ59250B , Lot Number 20LMB819 ;
DYNJ59250B , Lot Number 21AMD112 ;
DYNJ59250B , Lot Number 21BMD535 ;
DYNJ59250B , Lot Number 21CMB360 ;
DYNJ59250B , Lot Number 21EMA212 ;
DYNJ59250B , Lot Number 21FMA715 ;
DYNJ60126B , Lot Number 22DMC817 ;
DYNJ60126B , Lot Number 22FME975 ;
DYNJ60126B , Lot Number 22IMG387 ;
DYNJ60126B , Lot Number 22KMA517 ;
DYNJ60126B , Lot Number 23BMC940 ;
DYNJ60126B , Lot Number 23BMI394 ;
DYNJ60126B , Lot Number 23CMF847 ;
DYNJ60126B , Lot Number 23DMF461 ;
DYNJ60126B , Lot Number 23EMF694 ;
DYNJ60126B , Lot Number 23JMI216 ;
DYNJ60126B , Lot Number 23KMF321 ;
DYNJ60126B , Lot Number 23KMJ544 ;
DYNJ60686A , Lot Number 19HBA763 ;
DYNJ63797, Lot Number 19HBP133 ;
DYNJ65524, Lot Number 20CBX808 ;
DYNJ65524, Lot Number 20GBT243 ;
DYNJ65524, Lot Number 20IBJ954 ;
DYNJ65524, Lot Number 21ABP007 ;
DYNJ66034A , Lot Number 22FBE056 ;
DYNJ66034A , Lot Number 22HBT057 ;
DYNJ66034A , Lot Number 22JBI274 ;
DYNJ66034A , Lot Number 22JBY015 ;
DYNJ66034A , Lot Number 22LBP732 ;
DYNJ66034A , Lot Number 23ABL743 ;
DYNJ66034A , Lot Number 23CBL351 ;
DYNJ66034A , Lot Number 23CBW295 ;
DYNJ66034A , Lot Number 23EBT384 ;
DYNJ66034A , Lot Number 23EBT758 ;
DYNJ66034A , Lot Number 23GBJ043 ;
DYNJ66034A , Lot Number 23HBQ666 ;
DYNJ66034A , Lot Number 23IBW230 ;
DYNJ66034A , Lot Number 23JBX037 ;
DYNJ66034A , Lot Number 23LBU935 ;
DYNJ66447, Lot Number 21JBO555 ;
DYNJ66447, Lot Number 21KBC098 ;
DYNJ66447, Lot Number 21KBV126 ;
DYNJ66447, Lot Number 21LBP144 ;
DYNJ66447, Lot Number 22DBO407 ;
DYNJ66447, Lot Number 22DBO928 ;
DYNJ66447, Lot Number 22HBR972 ;
DYNJ66447, Lot Number 22JBF016 ;
DYNJ66447, Lot Number 23JBM687 ;
DYNJ66447, Lot Number 23LBN206 ;
DYNJ66596, Lot Number 20GBI925 ;
DYNJ67382B , Lot Number 23EMF017 ;
DYNJ67382B , Lot Number 23GMC927 ;
DYNJ67382B , Lot Number 23HMC443 ;
DYNJ67382B , Lot Number 23IME008 ;
DYNJ67382B , Lot Number 23JMH559 ;
DYNJ67382B , Lot Number 23LMC243 ;
DYNJ68141, Lot Number 21CBK909 ;
DYNJ68141, Lot Number 21DBJ222 ;
DYNJ81490, Lot Number 22EBG821 ;
DYNJ81490, Lot Number 22HBG106 ;
DYNJ81490, Lot Number 22HBY318 ;
DYNJ81490, Lot Number 22KBP817 ;
DYNJ81490, Lot Number 23BBF609 ;
DYNJ81539, Lot Number 22HBR010 ;
DYNJ81539, Lot Number 22LBQ876 ;
DYNJ81539, Lot Number 23ABU720 ;
DYNJ81539, Lot Number 23CBI016 ;
DYNJ83704A , Lot Number 23FMF339 ;
DYNJ83704A , Lot Number 23HME942 ;
DYNJ83704A , Lot Number 23HMF394 ;
DYNJ83704A , Lot Number 23HMF701 ;
DYNJ900509N, Lot Number 22JBW691 ;
DYNJ900509N, Lot Number 22LBG812 ;
DYNJ900509N, Lot Number 23ABM561 ;
DYNJ900509N, Lot Number 23BBR703 ;
DYNJ900509O, Lot Number 23FBK476 ;
DYNJ900509O, Lot Number 23HBX994 ;
DYNJ900509O, Lot Number 23IBN416 ;
DYNJ900509O, Lot Number 23JBT820 ;
DYNJ900509O, Lot Number 23KBP934 ;
DYNJ900525C, Lot Number 19KBI868 ;
DYNJ900525C, Lot Number 20BBI322 ;
DYNJ900525C, Lot Number 20CBO862 ;
DYNJ903026F, Lot Number 20BBK717 ;
DYNJ903026F, Lot Number 20CBX723 ;
DYNJ903026G, Lot Number 20DBT281 ;
DYNJ903026G, Lot Number 20FBA151 ;
DYNJ903026G, Lot Number 20FBT932 ;
DYNJ903026G, Lot Number 20HBG899 ;
DYNJ903026G, Lot Number 20IBS987 ;
DYNJ903026G, Lot Number 20KBJ534 ;
DYNJ903421D, Lot Number 19EBI945 ;
DYNJ903421D, Lot Number 19FBN494 ;
DYNJ903421D, Lot Number 19HBG628 ;
DYNJ903421D, Lot Number 19HBM256 ;
DYNJ903421D, Lot Number 19JBX085 ;
DYNJ903421D, Lot Number 19LBB732 ;
DYNJ903421D, Lot Number 20ABP122 ;
DYNJ903421D, Lot Number 20CBC110 ;
DYNJ903421D, Lot Number 20EBA325 ;
DYNJ903421D, Lot Number 20FBG639 ;
DYNJ903421D, Lot Number 20GBR856 ;
DYNJ903421D, Lot Number 20IBB212 ;
DYNJ903521A, Lot Number 19BBR865 ;
DYNJ903521A, Lot Number 19CBT729 ;
DYNJ903521A, Lot Number 19GBA961 ;
DYNJ903521A, Lot Number 19VBE306 ;
DYNJ903521A, Lot Number 20BBD187 ;
DYNJ903826F, Lot Number 23ABJ844 ;
DYNJ903826F, Lot Number 23ABS418 ;
DYNJ903826F, Lot Number 23BBR653 ;
DYNJ904836A, Lot Number 19CBF679 ;
DYNJ904836A, Lot Number 19DBT189 ;
DYNJ904836A, Lot Number 19FBM782 ;
DYNJ904836A, Lot Number 19GBA138 ;
DYNJ904836A, Lot Number 19IBA466 ;
DYNJ904836A, Lot Number 19IBQ912 ;
DYNJ904836A, Lot Number 19KBK072 ;
DYNJ904836A, Lot Number 19LBP264 ;
DYNJ904836A, Lot Number 20BBC548 ;
DYNJ904836B, Lot Number 20ABM050 ;
DYNJ904836B, Lot Number 20CBB774 ;
DYNJ904836C, Lot Number 20CBU472 ;
DYNJ904836D, Lot Number 20FBF337 ;
DYNJ904836D, Lot Number 20IBD212 ;
DYNJ904836D, Lot Number 20JBD003 ;
DYNJ904836D, Lot Number 20JBD122 ;
DYNJ904836D, Lot Number 20JBX884 ;
DYNJ906574 , Lot Number 20CBH955 ;
DYNJ906574 , Lot Number 20EBU071 ;
DYNJ906574 , Lot Number 20FBB155 ;
DYNJ906574 , Lot Number 20FBJ594 ;
DYNJ906574 , Lot Number 20FBO709 ;
DYNJ906574 , Lot Number 20FBP489 ;
DYNJ906574 , Lot Number 20FBU277 ;
DYNJ906574 , Lot Number 20GBB134 ;
DYNJ906574 , Lot Number 20HBN043 ;
DYNJ908362B, Lot Number 23FLA515 ;
DYNJ908362B, Lot Number 23HLA926 ;
DYNJ908362B, Lot Number 23ILA611 ;
DYNJ908362B, Lot Number 23JLA551 ;
DYNJ908362B, Lot Number 23KLA222 ;
DYNJ908362B, Lot Number 23LLA801 ;
P830355A , Lot Number 23LME416 ;
P830355AH, Lot Number 23LME416 |
Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
|
| For Additional Information Contact | Karin Johnson
886-359-1704 |
|---|
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 04/08/2024 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 these 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. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods. |
|---|
| Distribution | Worldwide distribution. |
|---|
| 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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