| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | April 08, 2024 |
|---|
| Date Posted | September 06, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-3045-2024 |
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| Recall Event ID |
94583 |
| Product Classification |
Pelvic exam kit - Product Code MLT
|
| Product | Medline Convenience kits labeled as:
1) GROTH PELVISCOPY CDS, Pack Number CDS984187T ;
2) GROTH PELVISCOPY, Pack Number CDS984187U ;
3) DERMATOLOGY KIT, Pack Number DYNDA1567D;
4) ER MINOR SUTURE SET, Pack Number DYNDA1977A;
5) HSG TRAY, Pack Number DYNDH1453;
6) TRAY, ER LACERATION, Pack Number DYNDL1569A;
7) LAP/PELVISCOPY CSTM PK-LF , Pack Number DYNJ0157511K ;
8) SMSC-PELVISCOPY PACK-LF , Pack Number DYNJ0161619I ;
9) LAPAROSCOPY/PELVISCOPY PACK-LF, Pack Number DYNJ0477038K ;
10) LITHOTOMY/PELVISCOPY PACK , Pack Number DYNJ0531985R ;
11) GYN PELVISCOPY PACK-LF, Pack Number DYNJ0537705L ;
12) SM-PELVISCOPY PACK-LF , Pack Number DYNJ0780009W ;
13) SM-PELVISCOPY PACK-LF , Pack Number DYNJ0780009Y ;
14) PELVISCOPY PACK-LF, Pack Number DYNJ0843760I ;
15) PELVISCOPY PACK-LF, Pack Number DYNJ0843760J ;
16) PELVISCOPY LAP-LF , Pack Number DYNJ40099B ;
17) PELVISCOPY LAP-LF , Pack Number DYNJ40099C ;
18) PELVISCOPY GYN LAP PACK , Pack Number DYNJ40608D ;
19) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595N ;
20) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595O ;
21) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595P ;
22) RFLAP PELVISCOPY PCK(LPLUH)-LF, Pack Number DYNJ47703G ;
23) PELVISCOPY PACK , Pack Number DYNJ50688D ;
24) PELVISCOPY PACK , Pack Number DYNJ50688F ;
25) HHI LITHOTOMY PELVISCOPY PACK , Pack Number DYNJ51918D ;
26) PELVIC LAP, Pack Number DYNJ53601G ;
27) VAGINAL PACK, Pack Number DYNJ59786B ;
28) PELVIC PACK , Pack Number DYNJ63057D ;
29) PELVIC PACK , Pack Number DYNJ63057F ;
30) PERI GYN, Pack Number DYNJ64239B ;
31) OB GYN PACK , Pack Number DYNJ80831;
32) MON OB GYN PACK , Pack Number DYNJ80831A ;
33) MON OB GYN PACK , Pack Number DYNJ80831B ;
34) LAP PELVISCOPY PACK , Pack Number DYNJ82449;
35) PELVISCOPY PACK , Pack Number DYNJ82555;
36) PELVISCOPY PACK , Pack Number DYNJ82555A ;
37) PELVISCOPY, Pack Number DYNJ82676;
38) PERIPELVIC PACK , Pack Number DYNJ83912;
39) PELVISCOPY PACK , Pack Number DYNJ84379;
40) PELVISCOPY PACK , Pack Number DYNJ85311;
41) D-PELVISCOPY, Pack Number DYNJ900628I;
42) PELVISCOPY, Pack Number DYNJ901655F;
43) PELVISCOPY, Pack Number DYNJ901655G;
44) PELVISCOPY, Pack Number DYNJ908446B;
45) NILES LAP PELVIC-LF , Pack Number DYNJ908459A;
46) NILES LAP PELVIC RFID-LF, Pack Number DYNJ908459B |
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| Code Information |
CDS984187T , Lot Number 22JBX647 ;
CDS984187T , Lot Number 22KBH092 ;
CDS984187T , Lot Number 22KBN639 ;
CDS984187T , Lot Number 23ABJ847 ;
CDS984187T , Lot Number 23DBN636 ;
CDS984187T , Lot Number 23EBN741 ;
CDS984187T , Lot Number 23FBO660 ;
CDS984187U , Lot Number 23GBV733 ;
CDS984187U , Lot Number 23HBA604 ;
CDS984187U , Lot Number 23JBE143 ;
CDS984187U , Lot Number 23JBE436 ;
CDS984187U , Lot Number 23JBX523 ;
CDS984187U , Lot Number 23LBN764 ;
CDS984187U , Lot Number 24BBN238 ;
CDS984187U , Lot Number 24BBU609 ;
DYNDA1567D, Lot Number 2019071090;
DYNDA1977A, Lot Number 2019071090;
DYNDH1453, Lot Number 2019071090;
DYNDL1569A, Lot Number 2019071090;
DYNJ0157511K , Lot Number 23LMI154 ;
DYNJ0161619I , Lot Number 23EMI816 ;
DYNJ0161619I , Lot Number 23FMC245 ;
DYNJ0161619I , Lot Number 23FMI370 ;
DYNJ0161619I , Lot Number 23HMB229 ;
DYNJ0161619I , Lot Number 23KMC793 ;
DYNJ0161619I , Lot Number 23KMF807 ;
DYNJ0477038K , Lot Number 23CBW969 ;
DYNJ0477038K , Lot Number 23EBW988 ;
DYNJ0477038K , Lot Number 23HBA845 ;
DYNJ0477038K , Lot Number 23IBP147 ;
DYNJ0477038K , Lot Number 23LBE881 ;
DYNJ0531985R , Lot Number 22HMF853 ;
DYNJ0531985R , Lot Number 22LMG691 ;
DYNJ0531985R , Lot Number 23AMF501 ;
DYNJ0531985R , Lot Number 23CMA603 ;
DYNJ0531985R , Lot Number 23DMG508 ;
DYNJ0537705L , Lot Number 23FMG696 ;
DYNJ0537705L , Lot Number 23IMC689 ;
DYNJ0780009W , Lot Number 22HMF696 ;
DYNJ0780009W , Lot Number 22JME002 ;
DYNJ0780009Y , Lot Number 23EMB610 ;
DYNJ0780009Y , Lot Number 23EMI825 ;
DYNJ0780009Y , Lot Number 23FMA234 ;
DYNJ0780009Y , Lot Number 23HMC653 ;
DYNJ0780009Y , Lot Number 23JMB180 ;
DYNJ0780009Y , Lot Number 23JMI648 ;
DYNJ0843760I , Lot Number 23DDA645 ;
DYNJ0843760I , Lot Number 23EDA680 ;
DYNJ0843760J , Lot Number 23JDA821 ;
DYNJ40099B , Lot Number 22ABP008 ;
DYNJ40099B , Lot Number 22BBW136 ;
DYNJ40099C , Lot Number 22FMB339 ;
DYNJ40099C , Lot Number 22HMA727 ;
DYNJ40099C , Lot Number 22IMG228 ;
DYNJ40099C , Lot Number 23BMG958 ;
DYNJ40099C , Lot Number 23BMH600 ;
DYNJ40099C , Lot Number 23DMD083 ;
DYNJ40099C , Lot Number 23DMG556 ;
DYNJ40099C , Lot Number 23FMJ765 ;
DYNJ40099C , Lot Number 23IMG857 ;
DYNJ40099C , Lot Number 23KMJ168 ;
DYNJ40099C , Lot Number 23LME309 ;
DYNJ40608D , Lot Number 23GBL162 ;
DYNJ40608D , Lot Number 23HBP723 ;
DYNJ40608D , Lot Number 23KBF077 ;
DYNJ40608D , Lot Number 23LBF535 ;
DYNJ47595N , Lot Number 23CMD083 ;
DYNJ47595O , Lot Number 23FMF971 ;
DYNJ47595P , Lot Number 23JMC128 ;
DYNJ47703G , Lot Number 23HME411 ;
DYNJ50688D , Lot Number 21HMG928 ;
DYNJ50688D , Lot Number 21HMH101 ;
DYNJ50688D , Lot Number 22AMG373 ;
DYNJ50688F , Lot Number 22HMH924 ;
DYNJ50688F , Lot Number 22KMC285 ;
DYNJ50688F , Lot Number 23EMA056 ;
DYNJ50688F , Lot Number 23GMF859 ;
DYNJ51918D , Lot Number 22IMA468 ;
DYNJ51918D , Lot Number 22KMB312 ;
DYNJ51918D , Lot Number 23AMA366 ;
DYNJ51918D , Lot Number 23DMG134 ;
DYNJ51918D , Lot Number 23HMI850 ;
DYNJ51918D , Lot Number 23IMC261 ;
DYNJ53601G , Lot Number 23HME948 ;
DYNJ53601G , Lot Number 23KMG377 ;
DYNJ59786B , Lot Number 21KMB136 ;
DYNJ59786B , Lot Number 22AME269 ;
DYNJ59786B , Lot Number 22DMF348 ;
DYNJ59786B , Lot Number 22EMF415 ;
DYNJ59786B , Lot Number 22FMB585 ;
DYNJ59786B , Lot Number 22GMG722 ;
DYNJ59786B , Lot Number 22IMG806 ;
DYNJ59786B , Lot Number 23AMH416 ;
DYNJ59786B , Lot Number 23DMC700 ;
DYNJ59786B , Lot Number 23EMF594 ;
DYNJ59786B , Lot Number 23EMK224 ;
DYNJ59786B , Lot Number 23FMD759 ;
DYNJ59786B , Lot Number 23FMI823 ;
DYNJ59786B , Lot Number 23GMG644 ;
DYNJ59786B , Lot Number 23JMG306 ;
DYNJ63057D , Lot Number 22HMB872 ;
DYNJ63057D , Lot Number 22JMC857 ;
DYNJ63057D , Lot Number 22KMD431 ;
DYNJ63057D , Lot Number 23CMC877 ;
DYNJ63057D , Lot Number 23EMB169 ;
DYNJ63057D , Lot Number 23GMF137 ;
DYNJ63057D , Lot Number 23HME622 ;
DYNJ63057D , Lot Number 23HMH140 ;
DYNJ63057F , Lot Number 23JMB899 ;
DYNJ64239B , Lot Number 23JMB243 ;
DYNJ80831, Lot Number 22BBE492 ;
DYNJ80831A , Lot Number 22EBH171 ;
DYNJ80831A , Lot Number 22FBD558 ;
DYNJ80831A , Lot Number 22HBD454 ;
DYNJ80831A , Lot Number 22IBL749 ;
DYNJ80831A , Lot Number 22KBP279 ;
DYNJ80831A , Lot Number 23BBB408 ;
DYNJ80831A , Lot Number 23CBP926 ;
DYNJ80831A , Lot Number 23DBC253 ;
DYNJ80831A , Lot Number 23EBJ251 ;
DYNJ80831A , Lot Number 23FBG917 ;
DYNJ80831B , Lot Number 23HBD666 ;
DYNJ80831B , Lot Number 23IBN212 ;
DYNJ80831B , Lot Number 23LBR042 ;
DYNJ82449, Lot Number 22HBJ902 ;
DYNJ82449, Lot Number 22LBD452 ;
DYNJ82449, Lot Number 23ABP213 ;
DYNJ82449, Lot Number 23EBO156 ;
DYNJ82449, Lot Number 23FBB975 ;
DYNJ82449, Lot Number 23FBC650 ;
DYNJ82449, Lot Number 23IBU101 ;
DYNJ82449, Lot Number 23JBL107 ;
DYNJ82449, Lot Number 24ABD321 ;
DYNJ82555, Lot Number 22HBQ035 ;
DYNJ82555, Lot Number 22KBI309 ;
DYNJ82555, Lot Number 22KBP238 ;
DYNJ82555, Lot Number 22LBF636 ;
DYNJ82555, Lot Number 23CBT455 ;
DYNJ82555, Lot Number 23DBP026 ;
DYNJ82555, Lot Number 23GBA449 ;
DYNJ82555, Lot Number 23HBR508 ;
DYNJ82555, Lot Number 23JBC557 ;
DYNJ82555A , Lot Number 23KBO623 ;
DYNJ82555A , Lot Number 24ABX191 ;
DYNJ82676, Lot Number 22JMA911 ;
DYNJ82676, Lot Number 23FMA638 ;
DYNJ82676, Lot Number 23FMF414 ;
DYNJ82676, Lot Number 23GMG485 ;
DYNJ82676, Lot Number 23HMC846 ;
DYNJ82676, Lot Number 23KMJ343 ;
DYNJ82676, Lot Number 24AMA022 ;
DYNJ82676, Lot Number 24AMC425 ;
DYNJ83912, Lot Number 23CME427 ;
DYNJ83912, Lot Number 23GMH710 ;
DYNJ83912, Lot Number 23HMF033 ;
DYNJ83912, Lot Number 23KMC978 ;
DYNJ84379, Lot Number 23EBH463 ;
DYNJ84379, Lot Number 23HBM856 ;
DYNJ84379, Lot Number 23KBQ889 ;
DYNJ84379, Lot Number 23LBH373 ;
DYNJ84379, Lot Number 24ABD682 ;
DYNJ84379, Lot Number 24ABV676 ;
DYNJ85311, Lot Number 23KBA927 ;
DYNJ900628I, Lot Number 22HDB961 ;
DYNJ900628I, Lot Number 22JDB340 ;
DYNJ900628I, Lot Number 22LDA537 ;
DYNJ900628I, Lot Number 23ADA741 ;
DYNJ900628I, Lot Number 23BDB733 ;
DYNJ900628I, Lot Number 23DDA544 ;
DYNJ900628I, Lot Number 23GDA869 ;
DYNJ900628I, Lot Number 23HDB017 ;
DYNJ900628I, Lot Number 23IDB957 ;
DYNJ900628I, Lot Number 23KDA160 ;
DYNJ900628I, Lot Number 24ADA433 ;
DYNJ900628I, Lot Number 24BDC032 ;
DYNJ901655F, Lot Number 22GBD980 ;
DYNJ901655F, Lot Number 22GBD982 ;
DYNJ901655F, Lot Number 22GBT479 ;
DYNJ901655F, Lot Number 23CBD840 ;
DYNJ901655F, Lot Number 23EBJ339 ;
DYNJ901655F, Lot Number 23GBN897 ;
DYNJ901655F, Lot Number 23HBP972 ;
DYNJ901655G, Lot Number 24ABG031 ;
DYNJ901655G, Lot Number 24ABI423 ;
DYNJ908446B, Lot Number 22LBH624 ;
DYNJ908446B, Lot Number 23ABS849 ;
DYNJ908446B, Lot Number 23EBA958 ;
DYNJ908446B, Lot Number 23FBD994 ;
DYNJ908446B, Lot Number 23HBS818 ;
DYNJ908446B, Lot Number 23JBO876 ;
DYNJ908446B, Lot Number 23LBC750 ;
DYNJ908459A, Lot Number 22IBE741 ;
DYNJ908459A, Lot Number 22KBP958 ;
DYNJ908459A, Lot Number 22LBC310 ;
DYNJ908459A, Lot Number 23BBA984 ;
DYNJ908459A, Lot Number 23CBX677 ;
DYNJ908459B, Lot Number 23FBA018 ;
DYNJ908459B, Lot Number 23FBA871 ;
DYNJ908459B, Lot Number 23GBU424 ;
DYNJ908459B, Lot Number 23IBA583 ;
DYNJ908459B, Lot Number 23LBD444 ;
DYNJ908459B, Lot Number 23LBP311 |
Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
|
| For Additional Information Contact | Karin Johnson
886-359-1704 |
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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 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. |
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| Distribution | Worldwide distribution. |
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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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