| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | April 08, 2024 |
|---|
| Date Posted | September 06, 2024 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2999-2024 |
|---|
| Recall Event ID |
94583 |
| Product Classification |
General purpose dental tray - Product Code OFX
|
| Product | Medline Convenience kits labeled as:
1) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010J ;
2) ORAL SURGERY PACK , Pack Number DYNJ00354K ;
3) ORAL PACK-LF, Pack Number DYNJ0426048L ;
4) ORAL SURGERY PACK-LF, Pack Number DYNJ17477F ;
5) ORAL SURGERY PACK-LF, Pack Number DYNJ17477G ;
6) ORAL SURGERY PACK-LF, Pack Number DYNJ20491N ;
7) DENTAL PACK-LF, Pack Number DYNJ36724C ;
8) DENTAL PACK WRM-LF, Pack Number DYNJ41963C ;
9) DENTAL SURGICOUNT , Pack Number DYNJ45540D ;
10) DENTAL PACK , Pack Number DYNJ49021F ;
11) DENTAL PACK , Pack Number DYNJ49021G ;
12) EXTRACTION PACK , Pack Number DYNJ49329F ;
13) CSC-N ORAL SURGERY PACK , Pack Number DYNJ50873B ;
14) ORAL SURGERY PACK , Pack Number DYNJ52404D ;
15) ORAL SURGERY PACK , Pack Number DYNJ52404F ;
16) ORAL SURGERY PACK , Pack Number DYNJ52404G ;
17) ORAL SURGERY PK RFID, Pack Number DYNJ52404I ;
18) WCMC PEDS DENTAL PACK , Pack Number DYNJ56307A ;
19) MAJOR PERIO DENTAL KIT, Pack Number DYNJ58157A ;
20) MAJOR PERIO DENTAL KIT, Pack Number DYNJ58157B ;
21) SURGERY KIT , Pack Number DYNJ58158A ;
22) SURGERY KIT , Pack Number DYNJ58158B ;
23) ORL PACK, Pack Number DYNJ59073B ;
24) ORAL SURGERY, Pack Number DYNJ59941B ;
25) ORAL SURGERY, Pack Number DYNJ59941BH;
26) MINOR DENTAL PACK-LF, Pack Number DYNJ61727I ;
27) MINOR DENTAL PACK-LF, Pack Number DYNJ61727J ;
28) MINOR DENTAL PACK-LF, Pack Number DYNJ61727K ;
29) MINOR DENTAL PACK-LF, Pack Number DYNJ61727L ;
30) DENTAL PACK , Pack Number DYNJ62779D ;
31) DENTAL PACK , Pack Number DYNJ62779F ;
32) DENTAL PACK , Pack Number DYNJ62779G ;
33) ORAL SURGERY PACK , Pack Number DYNJ66450B ;
34) ORAL PACK NTX , Pack Number DYNJ68506C ;
35) ORAL MAXILOFACIAL PK, Pack Number DYNJ80226A ;
36) ORAL MAXILOFACIAL PK, Pack Number DYNJ80226B ;
37) ORAL MAXILOFACIAL PK, Pack Number DYNJ80226C ;
38) ORAL MAXILOFACIAL PK, Pack Number DYNJ80226D ;
39) ORAL MAXILOFACIAL PK, Pack Number DYNJ80226DH;
40) DENTAL PACK , Pack Number DYNJ80375;
41) ORAL SURGERY PACK , Pack Number DYNJ80619;
42) ORAL SURGERY PACK , Pack Number DYNJ80619A ;
43) DEAN DENTAL PACK, Pack Number DYNJ80644;
44) DEAN DENTAL PACK, Pack Number DYNJ80644A ;
45) DENTAL MINOR PACK , Pack Number DYNJ83140;
46) DENTAL PACK , Pack Number DYNJ84533;
47) ORAL SURGERY PACK-LF, Pack Number DYNJ84849;
48) ORAL, Pack Number DYNJ902377G;
49) ORAL SURGERY PACK-LF, Pack Number DYNJ904595D;
50) NYGH-MAJOR DENTAL-LF, Pack Number DYNJ905540F;
51) NYGH-MINOR DENTAL-PLASTIC-LF, Pack Number DYNJ905551C;
52) NORTH DENTAL, Pack Number DYNJ906941B;
53) ORAL, Pack Number DYNJ908371 ;
54) ORAL, Pack Number DYNJ908371A;
55) ORAL, Pack Number DYNJ908371B;
56) ORAL, Pack Number DYNJ908371C;
57) DENTAL, Pack Number DYNJ909635 ;
58) DENTAL, Pack Number DYNJ909635A |
|---|
| Code Information |
CDS983010J ; Lot Number 22BBC009 ;
CDS983010J ; Lot Number 22IBC611 ;
CDS983010J ; Lot Number 22IBT150 ;
CDS983010J ; Lot Number 22JBR866 ;
CDS983010J ; Lot Number 23BBA121 ;
CDS983010J ; Lot Number 23GBD710 ;
CDS983010J ; Lot Number 23IBK805 ;
CDS983010J ; Lot Number 23IBW114 ;
CDS983010J ; Lot Number 23LMH952 ;
DYNJ00354K ; Lot Number 23GMD230 ;
DYNJ00354K ; Lot Number 23HMI535 ;
DYNJ00354K ; Lot Number 23LMC320 ;
DYNJ00354K ; Lot Number 23LMH116 ;
DYNJ0426048L ; Lot Number 21FLA383 ;
DYNJ0426048L ; Lot Number 21GLA406 ;
DYNJ0426048L ; Lot Number 21GLB217 ;
DYNJ0426048L ; Lot Number 21ILA230 ;
DYNJ0426048L ; Lot Number 21JLA322 ;
DYNJ0426048L ; Lot Number 21KLA413 ;
DYNJ17477F ; Lot Number 22OBL759 ;
DYNJ17477F ; Lot Number 22DBE452 ;
DYNJ17477F ; Lot Number 22EBP359 ;
DYNJ17477F ; Lot Number 22GBA339 ;
DYNJ17477F ; Lot Number 22GBK261 ;
DYNJ17477F ; Lot Number 22GBS374 ;
DYNJ17477F ; Lot Number 22GBU600 ;
DYNJ17477G ; Lot Number 22LBE020 ;
DYNJ17477G ; Lot Number 23ABO736 ;
DYNJ17477G ; Lot Number 23BBP921 ;
DYNJ17477G ; Lot Number 23CBV133 ;
DYNJ17477G ; Lot Number 23EBI573 ;
DYNJ17477G ; Lot Number 23FBB745 ;
DYNJ17477G ; Lot Number 23GBR631 ;
DYNJ17477G ; Lot Number 23HBO131 ;
DYNJ17477G ; Lot Number 23HBP963 ;
DYNJ17477G ; Lot Number 23LBB041 ;
DYNJ20491N ; Lot Number 21JDB764 ;
DYNJ20491N ; Lot Number 21LDB850 ;
DYNJ20491N ; Lot Number 22BDA344 ;
DYNJ20491N ; Lot Number 22CDB501 ;
DYNJ20491N ; Lot Number 22DDB894 ;
DYNJ20491N ; Lot Number 22FDB186 ;
DYNJ20491N ; Lot Number 22IDA002 ;
DYNJ20491N ; Lot Number 22LDC230 ;
DYNJ20491N ; Lot Number 23ADB460 ;
DYNJ20491N ; Lot Number 23CDA315 ;
DYNJ20491N ; Lot Number 23CDB899 ;
DYNJ20491N ; Lot Number 23FDA431 ;
DYNJ20491N ; Lot Number 23GDB331 ;
DYNJ20491N ; Lot Number 23HDC417 ;
DYNJ20491N ; Lot Number 23JDB061 ;
DYNJ20491N ; Lot Number 23LDB174 ;
DYNJ20491N ; Lot Number 24BDA747 ;
DYNJ36724C ; Lot Number 22EBK043 ;
DYNJ36724C ; Lot Number 22GBK775 ;
DYNJ36724C ; Lot Number 22KBG650 ;
DYNJ36724C ; Lot Number 22LBE175 ;
DYNJ36724C ; Lot Number 23DBI636 ;
DYNJ36724C ; Lot Number 23EBQ403 ;
DYNJ36724C ; Lot Number 23GBP614 ;
DYNJ36724C ; Lot Number 23GBT509 ;
DYNJ36724C ; Lot Number 23IBH010 ;
DYNJ41963C ; Lot Number 22DBH065 ;
DYNJ41963C ; Lot Number 22EBK002 ;
DYNJ41963C ; Lot Number 23CBI989 ;
DYNJ41963C ; Lot Number 23DBH040 ;
DYNJ41963C ; Lot Number 23GBA695 ;
DYNJ41963C ; Lot Number 23HBG324 ;
DYNJ41963C ; Lot Number 23KBX715 ;
DYNJ45540D ; Lot Number 21GBW473 ;
DYNJ45540D ; Lot Number 21IBN344 ;
DYNJ45540D ; Lot Number 21KBR959 ;
DYNJ45540D ; Lot Number 21LBR595 ;
DYNJ45540D ; Lot Number 22BBK035 ;
DYNJ45540D ; Lot Number 22DBR818 ;
DYNJ45540D ; Lot Number 22HBN230 ;
DYNJ45540D ; Lot Number 22HBN967 ;
DYNJ45540D ; Lot Number 22IBL354 ;
DYNJ45540D ; Lot Number 23BBE006 ;
DYNJ45540D ; Lot Number 23EBN239 ;
DYNJ45540D ; Lot Number 23FBT246 ;
DYNJ45540D ; Lot Number 23IBM404 ;
DYNJ49021F ; Lot Number 23HDB283 ;
DYNJ49021G ; Lot Number 24ADC003 ;
DYNJ49329F ; Lot Number 22EBB108 ;
DYNJ49329F ; Lot Number 22GBR442 ;
DYNJ49329F ; Lot Number 22HBR730 ;
DYNJ49329F ; Lot Number 22LBH164 ;
DYNJ49329F ; Lot Number 22LBH169 ;
DYNJ49329F ; Lot Number 22LBJ856 ;
DYNJ49329F ; Lot Number 23GBH478 ;
DYNJ49329F ; Lot Number 23GBS792 ;
DYNJ49329F ; Lot Number 23HBJ404 ;
DYNJ49329F ; Lot Number 23IBL117 ;
DYNJ49329F ; Lot Number 23KBL247 ;
DYNJ49329F ; Lot Number 23LBE302 ;
DYNJ50873B ; Lot Number 22FMC506 ;
DYNJ50873B ; Lot Number 23AMD590 ;
DYNJ50873B ; Lot Number 23CMB861 ;
DYNJ52404D ; Lot Number 21IDA311 ;
DYNJ52404D ; Lot Number 21IDC346 ;
DYNJ52404D ; Lot Number 21LDB538 ;
DYNJ52404F ; Lot Number 22BDB993 ;
DYNJ52404F ; Lot Number 22CDB805 ;
DYNJ52404G ; Lot Number 22HDB737 ;
DYNJ52404G ; Lot Number 22IDA539 ;
DYNJ52404G ; Lot Number 22KDA882 ;
DYNJ52404I ; Lot Number 23EDA538 ;
DYNJ52404I ; Lot Number 23FDC351 ;
DYNJ52404I ; Lot Number 23HDB384 ;
DYNJ52404I ; Lot Number 23IDC338 ;
DYNJ56307A ; Lot Number 23ABD150 ;
DYNJ56307A ; Lot Number 23BBB625 ;
DYNJ56307A ; Lot Number 23CBW951 ;
DYNJ56307A ; Lot Number 23EBH936 ;
DYNJ56307A ; Lot Number 23FBB061 ;
DYNJ56307A ; Lot Number 23HBB009 ;
DYNJ56307A ; Lot Number 23IBI467 ;
DYNJ56307A ; Lot Number 23JBS836 ;
DYNJ58157A ; Lot Number 21FME509 ;
DYNJ58157A ; Lot Number 21IMF607 ;
DYNJ58157A ; Lot Number 21JMG595 ;
DYNJ58157B ; Lot Number 21LMC008 ;
DYNJ58157B ; Lot Number 22AME233 ;
DYNJ58157B ; Lot Number 22CMI562 ;
DYNJ58157B ; Lot Number 22HMF125 ;
DYNJ58157B ; Lot Number 23AMH028 ;
DYNJ58157B ; Lot Number 23DMA886 ;
DYNJ58157B ; Lot Number 23EMH308 ;
DYNJ58157B ; Lot Number 23JMB317 ;
DYNJ58157B ; Lot Number 23JMJ548 ;
DYNJ58157B ; Lot Number 23KMJ285 ;
DYNJ58158A ; Lot Number 21LMG842 ;
DYNJ58158A ; Lot Number 22EMC770 ;
DYNJ58158A ; Lot Number 22FMB369 ;
DYNJ58158A ; Lot Number 22FMH686 ;
DYNJ58158A ; Lot Number 22HMC012 ;
DYNJ58158A ; Lot Number 22HMF727 ;
DYNJ58158B ; Lot Number 22IMG255 ;
DYNJ58158B ; Lot Number 22LMI669 ;
DYNJ58158B ; Lot Number 22LMI675 ;
DYNJ58158B ; Lot Number 23CMC282 ;
DYNJ58158B ; Lot Number 23EMA456 ;
DYNJ58158B ; Lot Number 23FMH442 ;
DYNJ58158B ; Lot Number 23GMC744 ;
DYNJ58158B ; Lot Number 23HMB209 ;
DYNJ58158B ; Lot Number 23KMB074 ;
DYNJ58158B ; Lot Number 23LMB171 ;
DYNJ59073B ; Lot Number 22IBK839 ;
DYNJ59073B ; Lot Number 22JBI913 ;
DYNJ59073B ; Lot Number 22KBK454 ;
DYNJ59073B ; Lot Number 22LBQ309 ;
DYNJ59073B ; Lot Number 23BBA464 ;
DYNJ59073B ; Lot Number 23CBG401 ;
DYNJ59073B ; Lot Number 23CBU743 ;
DYNJ59073B ; Lot Number 23EBL522 ;
DYNJ59073B ; Lot Number 23GBE642 ;
DYNJ59073B ; Lot Number 23GBU324 ;
DYNJ59073B ; Lot Number 23HBA871 ;
DYNJ59073B ; Lot Number 23IBA626 ;
DYNJ59073B ; Lot Number 23IBS781 ;
DYNJ59073B ; Lot Number 23KBL505 ;
DYNJ59941B ; Lot Number 21LBF565 ;
DYNJ59941B ; Lot Number 22ABU134 ;
DYNJ59941B ; Lot Number 22BBH754 ;
DYNJ59941B ; Lot Number 22FBU080 ;
DYNJ59941B ; Lot Number 22IBG644 ;
DYNJ59941B ; Lot Number 22JBG893 ;
DYNJ59941B ; Lot Number 22JBQ925 ;
DYNJ59941B ; Lot Number 22KBL124 ;
DYNJ59941B ; Lot Number 23ABD993 ;
DYNJ59941B ; Lot Number 23BBA808 ;
DYNJ59941B ; Lot Number 23CBM134 ;
DYNJ59941B ; Lot Number 23FBV200 ;
DYNJ59941B ; Lot Number 23HBJ311 ;
DYNJ59941B ; Lot Number 23JBC693 ;
DYNJ59941B ; Lot Number 23KBT719 ;
DYNJ59941B ; Lot Number 24ABA734 ;
DYNJ59941BH; Lot Number 21LBF565 ;
DYNJ59941BH; Lot Number 22ABU134 ;
DYNJ59941BH; Lot Number 22BBH754 ;
DYNJ59941BH; Lot Number 22FBU080 ;
DYNJ59941BH; Lot Number 22IBG644 ;
DYNJ59941BH; Lot Number 22JBG893 ;
DYNJ59941BH; Lot Number 22JBQ925 ;
DYNJ59941BH; Lot Number 22KBL124 ;
DYNJ59941BH; Lot Number 23ABD993 ;
DYNJ59941BH; Lot Number 23BBA808 ;
DYNJ59941BH; Lot Number 23CBM134 ;
DYNJ59941BH; Lot Number 23FBV200 ;
DYNJ59941BH; Lot Number 23HBJ311 ;
DYNJ59941BH; Lot Number 23JBC693 ;
DYNJ59941BH; Lot Number 23KBT719 ;
DYNJ59941BH; Lot Number 24ABA734 ;
DYNJ61727I ; Lot Number 21JBK294 ;
DYNJ61727J ; Lot Number 21LBD388 ;
DYNJ61727J ; Lot Number 22BBN014 ;
DYNJ61727J ; Lot Number 22CBF193 ;
DYNJ61727J ; Lot Number 22CMG015 ;
DYNJ61727J ; Lot Number 22EMI228 ;
DYNJ61727J ; Lot Number 22FMB017 ;
DYNJ61727J ; Lot Number 22FME781 ;
DYNJ61727J ; Lot Number 22GMG733 ;
DYNJ61727J ; Lot Number 22HMF449 ;
DYNJ61727K ; Lot Number 22JMI349 ;
DYNJ61727K ; Lot Number 23AMC095 ;
DYNJ61727K ; Lot Number 23CMD238 ;
DYNJ61727K ; Lot Number 23DMF668 ;
DYNJ61727K ; Lot Number 23EME231 ;
DYNJ61727K ; Lot Number 23EMH529 ;
DYNJ61727K ; Lot Number 23FMB563 ;
DYNJ61727K ; Lot Number 23GMC405 ;
DYNJ61727L ; Lot Number 23IMF670 ;
DYNJ61727L ; Lot Number 23IMI141 ;
DYNJ61727L ; Lot Number 23JMI361 ;
DYNJ61727L ; Lot Number 23KMA126 ;
DYNJ61727L ; Lot Number 23LMB824 ;
DYNJ62779D ; Lot Number 22EDA032 ;
DYNJ62779D ; Lot Number 22EDA489 ;
DYNJ62779F ; Lot Number 22HDA403 ;
DYNJ62779G ; Lot Number 23GDA168 ;
DYNJ62779G ; Lot Number 23GDB451 ;
DYNJ66450B ; Lot Number 22IBB948 ;
DYNJ66450B ; Lot Number 22KBV773 ;
DYNJ66450B ; Lot Number 23EBR729 ;
DYNJ66450B ; Lot Number 23JBW720 ;
DYNJ66450B ; Lot Number 23LBH114 ;
DYNJ68506C ; Lot Number 23DBS664 ;
DYNJ68506C ; Lot Number 23DBS853 ;
DYNJ68506C ; Lot Number 23FBG056 ;
DYNJ68506C ; Lot Number 23GBM557 ;
DYNJ68506C ; Lot Number 23HBN011 ;
DYNJ68506C ; Lot Number 23JBM846 ;
DYNJ68506C ; Lot Number 23LBC658 ;
DYNJ80226A ; Lot Number 22FBV173 ;
DYNJ80226A ; Lot Number 22FBV174 ;
DYNJ80226A ; Lot Number 22GBV225 ;
DYNJ80226B ; Lot Number 22HBC718 ;
DYNJ80226B ; Lot Number 22IBU418 ;
DYNJ80226B ; Lot Number 22JBI169 ;
DYNJ80226B ; Lot Number 22LBD065 ;
DYNJ80226C ; Lot Number 23ABG109 ;
DYNJ80226C ; Lot Number 23BBS329 ;
DYNJ80226C ; Lot Number 23EBD031 ;
DYNJ80226D ; Lot Number 23FBQ147 ;
DYNJ80226D ; Lot Number 23GBI193 ;
DYNJ80226D ; Lot Number 23HBD258 ;
DYNJ80226D ; Lot Number 23HBR280 ;
DYNJ80226D ; Lot Number 23KBT438 ;
DYNJ80226D ; Lot Number 24ABD298 ;
DYNJ80226D ; Lot Number 24ABU028 ;
DYNJ80226DH; Lot Number 23FBQ147 ;
DYNJ80226DH; Lot Number 23GBI193 ;
DYNJ80226DH; Lot Number 23HBD258 ;
DYNJ80226DH; Lot Number 23HBR280 ;
DYNJ80226DH; Lot Number 23KBT438 ;
DYNJ80226DH; Lot Number 24ABD298 ;
DYNJ80226DH; Lot Number 24ABU028 ;
DYNJ80375; Lot Number 22CBG092 ;
DYNJ80375; Lot Number 22EBQ917 ;
DYNJ80375; Lot Number 22IBQ585 ;
DYNJ80375; Lot Number 23FBS558 ;
DYNJ80375; Lot Number 23HBJ402 ;
DYNJ80619; Lot Number 22BMA820 ;
DYNJ80619; Lot Number 22DMH324 ;
DYNJ80619; Lot Number 22FMD997 ;
DYNJ80619A ; Lot Number 22IME438 ;
DYNJ80619A ; Lot Number 22KMC350 ;
DYNJ80619A ; Lot Number 22LMB169 ;
DYNJ80619A ; Lot Number 23BMB182 ;
DYNJ80619A ; Lot Number 23BMH351 ;
DYNJ80619A ; Lot Number 23DME515 ;
DYNJ80619A ; Lot Number 23EMI879 ;
DYNJ80644; Lot Number 22BDB904 ;
DYNJ80644; Lot Number 22DDB750 ;
DYNJ80644; Lot Number 23GDA137 ;
DYNJ80644; Lot Number 23GDB599 ;
DYNJ80644; Lot Number 23KDB158 ;
DYNJ80644A ; Lot Number 23KDC248 ;
DYNJ80644A ; Lot Number 24ADB620 ;
DYNJ83140; Lot Number 22JBN386 ;
DYNJ84533; Lot Number 23FBJ203 ;
DYNJ84533; Lot Number 23HBI888 ;
DYNJ84849; Lot Number 23HBQ884 ;
DYNJ902377G; Lot Number 22JBA943 ;
DYNJ902377G; Lot Number 22JBO834 ;
DYNJ902377G; Lot Number 22KBG529 ;
DYNJ902377G; Lot Number 22KBK524 ;
DYNJ902377G; Lot Number 23ABC461 ;
DYNJ902377G; Lot Number 23BBN939 ;
DYNJ902377G; Lot Number 23EBN577 ;
DYNJ904595D; Lot Number 22FBX893 ;
DYNJ904595D; Lot Number 22GBX101 ;
DYNJ904595D; Lot Number 22GBX102 ;
DYNJ904595D; Lot Number 22GBX452 ;
DYNJ904595D; Lot Number 23BBG733 ;
DYNJ904595D; Lot Number 23BBU681 ;
DYNJ904595D; Lot Number 23CBM716 ;
DYNJ904595D; Lot Number 23CBO282 ;
DYNJ904595D; Lot Number 23CBR749 ;
DYNJ904595D; Lot Number 23CBT365 ;
DYNJ905540F; Lot Number 23LBU879 ;
DYNJ905540F; Lot Number 24ABP739 ;
DYNJ905551C; Lot Number 23LBF673 ;
DYNJ905551C; Lot Number 24ABB211 ;
DYNJ905551C; Lot Number 24CBA921 ;
DYNJ905551C; Lot Number 24CBJ238 ;
DYNJ906941B; Lot Number 22FBM740 ;
DYNJ906941B; Lot Number 22GBT635 ;
DYNJ906941B; Lot Number 22KBO727 ;
DYNJ906941B; Lot Number 23ABC523 ;
DYNJ906941B; Lot Number 23ABQ444 ;
DYNJ906941B; Lot Number 23EBL207 ;
DYNJ906941B; Lot Number 23HBM842 ;
DYNJ906941B; Lot Number 23JBD314 ;
DYNJ906941B; Lot Number 23KBB990 ;
DYNJ906941B; Lot Number 24ABE237 ;
DYNJ906941B; Lot Number 24ABP612 ;
DYNJ906941B; Lot Number 22BDB731 ;
DYNJ906941B; Lot Number 22DDA710 ;
DYNJ908371 ; Lot Number 22ALA451 ;
DYNJ908371 ; Lot Number 22BLA143 ;
DYNJ908371 ; Lot Number 22BLA457 ;
DYNJ908371 ; Lot Number 22ELA506 ;
DYNJ908371 ; Lot Number 22FLB139 ;
DYNJ908371 ; Lot Number 22ILA735 ;
DYNJ908371 ; Lot Number 22JLA042 ;
DYNJ908371 ; Lot Number 22JLA376 ;
DYNJ908371 ; Lot Number 22JLB047 ;
DYNJ908371 ; Lot Number 22LLA214 ;
DYNJ908371A; Lot Number 23BLA843 ;
DYNJ908371A; Lot Number 23DLA646 ;
DYNJ908371B; Lot Number 23GLA546 ;
DYNJ908371B; Lot Number 23ILA755 ;
DYNJ908371B; Lot Number 23JLB151 ;
DYNJ908371B; Lot Number 23KLB029 ;
DYNJ908371B; Lot Number 23LLB017 ;
DYNJ908371C; Lot Number 24BLA656 ;
DYNJ909635 ; Lot Number 23FBI195 ;
DYNJ909635A; Lot Number 23IBA327 ;
DYNJ909635A; Lot Number 23KBT027 |
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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