| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | April 08, 2024 |
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| Date Posted | September 06, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-3021-2024 |
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| Recall Event ID |
94583 |
| Product Classification |
I.V. start kit - Product Code LRS
|
| Product | Medline Convenience kits labeled as:
1) ECMO INSERTION BUNDLE W/O CANNULA, Pack Number CVI4915;
2) PORT ACCESS TRAY, Pack Number DYNDC1318D;
3) KNEE ARTHROSCOPY PACK-LF, Pack Number DYNJ0101308C ;
4) UNIVERSAL PLASTIC , Pack Number DYNJ04047C ;
5) JAM CATH LAB MINOR PACK , Pack Number DYNJ17507B ;
6) STARTER PACK CMH-LF , Pack Number DYNJ41737C ;
7) DELIVERY PACK ME-LF , Pack Number DYNJ45589B ;
8) STERILE STARTER SET PACK, Pack Number DYNJ47814;
9) IVF PACK, Pack Number DYNJ63783;
10) VI PACK , Pack Number DYNJ64811;
11) VI PACK , Pack Number DYNJ64871;
12) IR CENTRAL KIT, Pack Number DYNJ68285;
13) PICC KIT 4F SL PL MAX BARRIER, Pack Number PICC0011;
14) PICC KIT 4F SL PL MAX BARRIER, Pack Number PICC0012;
15) LACERATION TRAY, Pack Number SUT20955;
16) UMBILICAL VESSEL TRAY, Pack Number UVT1100A;
17) UMBILICAL INSERTION W/3.5 CATH, Pack Number UVT1225;
18) UMBILICAL INSERTION W/3.5 CATH, Pack Number UVT1225H ;
19) UMBILICAL TRAY W/3.5&5FR CATH , Pack Number UVT1250H |
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| Code Information |
CVI4915, Lot Number 2022103180;
DYNDC1318D, Lot Number 2019012590;
DYNJ0101308C , Lot Number 19BKC672 ;
DYNJ04047C , Lot Number 21FBN548 ;
DYNJ04047C , Lot Number 21GBL027 ;
DYNJ04047C , Lot Number 21IBX365 ;
DYNJ04047C , Lot Number 22ABM052 ;
DYNJ04047C , Lot Number 19ABD460 ;
DYNJ04047C , Lot Number 22CBP491 ;
DYNJ04047C , Lot Number 22OBI898 ;
DYNJ04047C , Lot Number 19FBD994 ;
DYNJ04047C , Lot Number 22IBH860 ;
DYNJ04047C , Lot Number 22IBJ054 ;
DYNJ04047C , Lot Number 22LBR925 ;
DYNJ04047C , Lot Number 19VBB656 ;
DYNJ04047C , Lot Number 23ABS681 ;
DYNJ04047C , Lot Number 19KBC727 ;
DYNJ04047C , Lot Number 19KBF911 ;
DYNJ04047C , Lot Number 20DBF312 ;
DYNJ04047C , Lot Number 20JBC775 ;
DYNJ17507B , Lot Number 19JDB044 ;
DYNJ17507B , Lot Number 20EDA752 ;
DYNJ17507B , Lot Number 20FDB395 ;
DYNJ17507B , Lot Number 20IDB921 ;
DYNJ17507B , Lot Number 20JDA956 ;
DYNJ17507B , Lot Number 20LDB169 ;
DYNJ17507B , Lot Number 21GDA031 ;
DYNJ17507B , Lot Number 21HDB179 ;
DYNJ17507B , Lot Number 21JDC732 ;
DYNJ17507B , Lot Number 23ADA442 ;
DYNJ41737C , Lot Number 21FBK597 ;
DYNJ41737C , Lot Number 21GBM874 ;
DYNJ41737C , Lot Number 21IBD142 ;
DYNJ41737C , Lot Number 21JBB598 ;
DYNJ41737C , Lot Number 21JBB602 ;
DYNJ41737C , Lot Number 21WBA194 ;
DYNJ41737C , Lot Number 21LBP147 ;
DYNJ41737C , Lot Number 22ABE433 ;
DYNJ41737C , Lot Number 19ABJ657 ;
DYNJ41737C , Lot Number 19CBB947 ;
DYNJ41737C , Lot Number 22OBI031 ;
DYNJ41737C , Lot Number 19CBO914 ;
DYNJ41737C , Lot Number 19DBC698 ;
DYNJ41737C , Lot Number 19DBO702 ;
DYNJ41737C , Lot Number 22FBJ538 ;
DYNJ41737C , Lot Number 19RBC166 ;
DYNJ41737C , Lot Number 22HBV259 ;
DYNJ41737C , Lot Number 19SBB262 ;
DYNJ41737C , Lot Number 22JBK898 ;
DYNJ41737C , Lot Number 19IBB771 ;
DYNJ41737C , Lot Number 19IBE072 ;
DYNJ41737C , Lot Number 19JBE636 ;
DYNJ41737C , Lot Number 19LBT637 ;
DYNJ41737C , Lot Number 20CBC820 ;
DYNJ41737C , Lot Number 23GBF976 ;
DYNJ41737C , Lot Number 23HBE132 ;
DYNJ41737C , Lot Number 20EBD652 ;
DYNJ41737C , Lot Number 20FBN024 ;
DYNJ41737C , Lot Number 23JBK069 ;
DYNJ41737C , Lot Number 23LBI143 ;
DYNJ41737C , Lot Number 20JBE583 ;
DYNJ41737C , Lot Number 21BBS926 ;
DYNJ41737C , Lot Number 21CBX913 ;
DYNJ45589B , Lot Number 18LBQ229 ;
DYNJ45589B , Lot Number 19BBI698 ;
DYNJ45589B , Lot Number 19EBB616 ;
DYNJ47814, Lot Number 19BBC131 ;
DYNJ47814, Lot Number 19DBQ381 ;
DYNJ47814, Lot Number 19GBA816 ;
DYNJ47814, Lot Number 19IBK685 ;
DYNJ47814, Lot Number 19KBJ696 ;
DYNJ47814, Lot Number 19LBU531 ;
DYNJ47814, Lot Number 20CBY831 ;
DYNJ47814, Lot Number 20FBI187 ;
DYNJ63783, Lot Number 21JBB671 ;
DYNJ63783, Lot Number 21KBJ500 ;
DYNJ63783, Lot Number 22BBF553 ;
DYNJ63783, Lot Number 22OBI679 ;
DYNJ63783, Lot Number 22EBE312 ;
DYNJ63783, Lot Number 22HBM741 ;
DYNJ63783, Lot Number 22IBH464 ;
DYNJ63783, Lot Number 19HBB067 ;
DYNJ63783, Lot Number 23DBJ842 ;
DYNJ63783, Lot Number 20ABM496 ;
DYNJ63783, Lot Number 23FBH844 ;
DYNJ63783, Lot Number 20CBL632 ;
DYNJ63783, Lot Number 23GBH242 ;
DYNJ63783, Lot Number 20EBH703 ;
DYNJ63783, Lot Number 23IBF782 ;
DYNJ63783, Lot Number 20HBD244 ;
DYNJ63783, Lot Number 20JBM648 ;
DYNJ63783, Lot Number 20JBW602 ;
DYNJ63783, Lot Number 20LBP393 ;
DYNJ63783, Lot Number 21DBP053 ;
DYNJ64811, Lot Number 19KBO216 ;
DYNJ64871, Lot Number 21IBR317 ;
DYNJ64871, Lot Number 21KBR802 ;
DYNJ64871, Lot Number 21KBR840 ;
DYNJ64871, Lot Number 22BBZ525 ;
DYNJ64871, Lot Number 22EBN632 ;
DYNJ64871, Lot Number 22GBV097 ;
DYNJ64871, Lot Number 22LBK474 ;
DYNJ64871, Lot Number 23ABB889 ;
DYNJ64871, Lot Number 19KBP348 ;
DYNJ64871, Lot Number 20ABR888 ;
DYNJ64871, Lot Number 23EBJ477 ;
DYNJ64871, Lot Number 20BBK386 ;
DYNJ64871, Lot Number 23FBO926 ;
DYNJ64871, Lot Number 23GBQ643 ;
DYNJ64871, Lot Number 23HBM974 ;
DYNJ64871, Lot Number 23KBF276 ;
DYNJ64871, Lot Number 20HBN235 ;
DYNJ64871, Lot Number 20KBG137 ;
DYNJ64871, Lot Number 20XBF536 ;
DYNJ64871, Lot Number 21BBL845 ;
DYNJ68285, Lot Number 21AME264 ;
PICC0011, Lot Number 2022030150;
PICC0011, Lot Number 2022061090;
PICC0012, Lot Number 2022022450;
SUT20955, Lot Number 2019012590;
UVT1100A, Lot Number 2022103180;
UVT1225, Lot Number 23BBJ869 ;
UVT1225, Lot Number 23DBN509 ;
UVT1225H , Lot Number 23BBJ869 ;
UVT1225H , Lot Number 23DBN509 ;
UVT1250H , Lot Number 23IBE795 ;
UVT1250H , Lot Number 23KBE411 |
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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