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Class 2 Device Recall Medline Convenience Kits

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Class 2 Device Recall Medline Convenience Kits

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Date Initiated by Firm	January 07, 2026
Date Posted	May 07, 2026
Recall Status¹	Open³, Classified
Recall Number	Z-2094-2026
Recall Event ID	98642
Product Classification	Central venous catheter tray - Product Code OFF
Product	Medline Convenience Kits: 1) PICC LINE TRAY, Model Number:00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Number:ACC010268B; 3) CODE CART ADULT 4 CENTRAL LINE, Model Number:ACC010268C; 4) TRAY 6 CENTRAL LINE A, Model Number:ACC010487; 5) PEDS PICC INSERTION TRAY, Model Number:CVI3650; 6) LINE ATTIRE KIT, Model Number:DYKM2170; 7) PK BNDL CENT LINE PROTECT KIT, Model Number:DYKM2274; 8) KIT SURG ONC LAP DIAG/PORT INS, Model Number:DYKMBNDL153C; 9) KIT SURG ONC INSERT CENT.VENOU, Model Number:DYKMBNDL43A; 10) KIT SURG ONC PORT INSERTION, Model Number:DYKMBNDL43C; 11) VEIN PROCEDURE KIT, Model Number:DYNDA2076B; 12) VEIN PROCEDURE KIT, Model Number:DYNDA2076D; 13) VEIN PROCEDURE KIT, Model Number:DYNDA2076F; 14) PLACENTA KIT, Model Number:DYNDA2322B; 15) NICU CENTRAL LINE TRAY, Model Number:DYNDC2407A; 16) NICU CENTRAL LINE TRAY, Model Number:DYNDC2407B; 17) PICC LINE TRAY, Model Number:DYNJ40500A; 18) VENOUS ACCESS PACK, Model Number:DYNJ42694C; 19) AV FISTULA CREATION PACK-LF, Model Number:DYNJ53427B; 20) PICC LINE, Model Number:DYNJ55546D; 21) PICC TRAY, Model Number:DYNJ63199A; 22) PICC KIT 4F SL PL MAX BARRIER, Model Number:DYNJ70141MB; 23) PICC KIT 5F DL PL MB, Model Number:DYNJ70152MB; 24) VEIN PACK, Model Number:DYNJ84239; 25) NEXTON PACK, Model Number:DYNJ88152; 26) PICC INSERTION TRAY W/O CATH, Model Number:PICCNC0004
Code Information	1) 00-401993O, UDI-DI: 10195327517366(each), 40195327517367(case), Lot Number: 23KBH528; 2) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21BDB379; 3) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21CDB078; 4) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21IDC222; 5) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21JDB458; 6) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22ADC105; 7) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22BDA862; 8) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22CDC433; 9) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22DDA763; 10) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22FDB218; 11) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23BDB271; 12) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23DDA455; 13) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23DDB175; 14) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23FDC048; 15) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23GDB567; 16) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23IDA297; 17) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 24DDA188; 18) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24HDB961; 19) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24IDB060; 20) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24JDB298; 21) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24KDA478; 22) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 25DDB786; 23) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 25EDA196; 24) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 21CDC422; 25) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 21LDB744; 26) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 22BDB354; 27) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23EDB085; 28) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23FDB587; 29) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23GDA369; 30) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23GDB672; 31) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23GDB680; 32) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23HDA348; 33) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 25ADB553; 34) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 25BDA733; 35) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 25BDB580; 36) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 25HDA748; 37) CVI3650, UDI-DI: 10653160256397(each), 40653160256398(case), Lot Number: 22EBO541; 38) DYKM2170, UDI-DI: 10195327200091(each), 40195327200092(case), Lot Number: 22IBN124; 39) DYKM2170, UDI-DI: 10195327200091(each), 40195327200092(case), Lot Number: 23ABC583; 40) DYKM2170, UDI-DI: 10195327200091(each), 40195327200092(case), Lot Number: 23BBA792; 41) DYKM2274, UDI-DI: 10198459278884(each), 40198459278885(case), Lot Number: 25HBK806; 42) DYKMBNDL153C, UDI-DI: 10198459000430(each), 40198459000431(case), Lot Number: 24DBR907; 43) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case), Lot Number: 22IBK412; 44) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case), Lot Number: 22IBM493; 45) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case).Lot Number: 23ABK335; 46) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case), Lot Number: 23BBS866; 47) DYKMBNDL43C, UDI-DI: 10198459000553(each), 40198459000554(case), Lot Number: 24DBS686; 48) DYNDA2076B, UDI-DI: 10195327572020(each), 40195327572021(case), Lot Number: 24ABI534; 49) DYNDA2076D, UDI-DI: 10198459216060(each), 40198459216061(case), Lot Number: 24LMH364; 50) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25FMF582; 51) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25HMH651; 52) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25IMA505; 53) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25KMH542; 54) DYNDA2322B, UDI-DI: 10195327299774(each), 40195327299775(case), Lot Number: 23FBW064; 55) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21ABI600; 56) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21DBA072; 57) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21JBV496; 58) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21LBT037; 59) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21OBA058; 60) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 22FME865; 61) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 23HMC992; 62) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 24AMB024; 63) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 24CMI922; 64) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 24DMF048; 65) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 24IMD214; 66) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 25EMA699; 67) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 25FMG170; 68) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 25IMA418; 69) DYNJ40500A, UDI-DI: 10195327350581(each), 40195327350582(case), Lot Number: 23FBG757; 70) DYNJ40500A, UDI-DI: 10195327350581(each), 40195327350582(case), Lot Number: 23HBB480; 71) DYNJ42694C, UDI-DI: 10195327514334(each), 40195327514335(case), Lot Number: 24ABW686; 72) DYNJ53427B, UDI-DI: 10193489248227(each), 40193489248228(case), Lot Number: 20LDC151; 73) DYNJ55546D, UDI-DI: 10195327056520(each), 40195327056521(case), Lot Number: 22IBQ424; 74) DYNJ55546D, UDI-DI: 10195327056520(each), 40195327056521(case), Lot Number: 22LBG357; 75) DYNJ55546D, UDI-DI: 10195327056520(each), 40195327056521(case), Lot Number: 23BBB100; 76) DYNJ55546D, UDI-DI: 10195327056520(each), 40195327056521(case), Lot Number: 23CBT475; 77) DYNJ55546D, UDI-DI: 10195327056520(each), 40195327056521(case), Lot Number: 23GBK664; 78) DYNJ63199A, UDI-DI: 10193489311730(each), 40193489311731(case), Lot Number: 22BBP290; 79) DYNJ63199A, UDI-DI: 10193489311730(each), 40193489311731(case), Lot Number: 22IBO930; 80) DYNJ63199A, UDI-DI: 10193489311730(each), 40193489311731(case), Lot Number: 22JBN171; 81) DYNJ63199A, UDI-DI: 10193489311730(each), 40193489311731(case), Lot Number: 24EBG970; 82) DYNJ63199A, UDI-DI: 10193489311730(each), 40193489311731(case), Lot Number: 25CBK996; 83) DYNJ70141MB, UDI-DI: 10889942722808(each), 40889942722809(case), Lot Number: 21ADA546; 84) DYNJ70152MB, UDI-DI: 10889942722822(each), 40889942722823(case), Lot Number: 21ADA547; 85) DYNJ84239, UDI-DI: 10195327345624(each), 40195327345625(case), Lot Number: 23FBJ937; 86) DYNJ88152, UDI-DI: 10198459110313(each), 40198459110314(case), Lot Number: 24IBL774; 87) DYNJ88152, UDI-DI: 10198459110313(each), 40198459110314(case), Lot Number: 24JBC005; 88) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 22CBY021; 89) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 22EBG055; 90) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 22LME863; 91) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 23BMF790; 92) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 23EMF082; 93) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 23JMG079; 94) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 23JMI718; 95) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 23LMA136; 96) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 23LMD502
FEI Number	1417592
Recalling Firm/ Manufacturer	Medline Industries, LP 3 Lakes Dr Northfield IL 60093-2753
For Additional Information Contact	Haley Barclay 866-359-1704
Manufacturer Reason for Recall	Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
FDA Determined Cause ²	Process control
Action	An URGENT MEDICAL DEVICE RECALL notification letter dated 1/7/26 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-003-FGX1 Recall Code: 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. An URGENT MEDICAL DEVICE RECALL notification letter dated 1/14/26 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-003-
Quantity in Commerce	5562 units
Distribution	Worldwide - US Nationwide distribution.
Total Product Life Cycle	TPLC Device Report

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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