Class 2 Device Recall Medline Convenience kits

• Date Initiated by Firm: March 03, 2025
• Date Posted: April 17, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1617-2025
• Recall Event ID: 96510
• Product Classification: Eye tray - Product Code OJK
• Product: Medline Convenience kits used for various procedures: 1) BASIC CATARACT, Model Number: DYNJ41097A; 2) PK EYE, Model Number: DYNJ60631B; 3) CATARACT PACK, Model Number: DYNJ80316A; 4) BASIC EYE PACK, Model Number: DYNJ63707C; 5) EYE PACK WITH ACCESSORY PACK, Model Number: DYNJ85284; 6) PHACO PACK, Model Number: DYNJ44748I; 7) CAROMONT EYE TRAY-LF, Model Number: DYNJ17004L; 8) CHOG MINOR OPHTHALMIC PACK, Model Number: SYNJ10271B; 9) LIFESPAN VITRECTOMY PACK, Model Number: DYNJ80082; 10) DR KEYS EYE PACK 2, Model Number: DYNJ48256M; 11) VITRECTOMY PACK, Model Number: DYNJ55508B; 12) EYE PACK, Model Number: DYNJ63952A; 13) VITRECTOMY, Model Number: DYNJ67309C; 14) CATARACT PACK-MARY IMMACUL-LF, Model Number: DYNJ24516F; 15) DR FLOOD EYE PACK, Model Number: DYNJ57258G; 16) BLEPH PACK, Model Number: DYNJ67875; 17) CAROMONT EYE TRAY-LF, Model Number: DYNJ17004L; 18) EYE PLASTIC PACK, Model Number: DYNJ47859C; 19) OPHTHALMOLOGY PACK, Model Number: SYNJ10259A; 20) PLASTIC EYE, Model Number: DYNJ45667C; 21) BASIC EYE PACK, Model Number: DYNJ81548B; 22) WMC CATARACT PACK-LF, Model Number: DYNJ50653F; 23) BASIC CATARACT, Model Number: DYNJ41097A; 24) PK EYE, Model Number: DYNJ60631B; 25) EYE PLASTIC SURGERY PACK, Model Number: DYNJ44061; 26) CATARACT, Model Number: DYNJ44544F; 27) CATARACT PACK, Model Number: DYNJ49515D; 28) CATARACT PACK, Model Number: DYNJ35438F; 29) OPHTHALMIC PLASTIC PACK, Model Number: DYNJ55208A; 30) CATARACT PACK, Model Number: DYNJ81534B; 31) CATARACT PACK, Model Number: DYNJ49515D
• Code Information: 1) DYNJ41097A, UDI-DI: 10888277213487(each), 40888277213488(case), Lot Number: 24IBF244; 2) DYNJ60631B, UDI-DI: 10193489994421(each), 40193489994422(case), Lot Number: 24IBG352; 3) DYNJ80316A, UDI-DI: 10195327245221(each), 40195327245222(case), Lot Number: 24IBG593; 4) DYNJ63707C, UDI-DI: 10193489883503(each), 40193489883504(case), Lot Number: 24IBH027; 5) DYNJ85284, UDI-DI: 10195327486457(each), 40195327486458(case), Lot Number: 24IBH266; 6) DYNJ44748I, UDI-DI: 10193489273458(each), 40193489273459(case), Lot Number: 24IBH805; 7) DYNJ17004L, UDI-DI: 10193489244144(each), 40193489244145(case), Lot Number: 24IBS294; 8) SYNJ10271B, UDI-DI: 10193489457209(each), 40193489457200(case), Lot Number: 24IBS393; 9) DYNJ80082, UDI-DI: 10195327012007(each), 40195327012008(case), Lot Number: 24IBS417; 10) DYNJ48256M, UDI-DI: 10195327466176(each), 40195327466177(case), Lot Number: 24JBJ668; 11) DYNJ55508B, UDI-DI: 10195327266912(each), 40195327266913(case), Lot Number: 24JBN908; 12) DYNJ63952A, UDI-DI: 10193489393958(each), 40193489393959(case), Lot Number: 24JBT060; 13) DYNJ67309C, UDI-DI: 10195327668990(each), 40195327668991(case), Lot Number: 24JBT766; 14) DYNJ24516F, UDI-DI: 10195327278458(each), 40195327278459(case), Lot Number: 24JBU088; 15) DYNJ57258G, UDI-DI: 10195327491123(each), 40195327491124(case), Lot Number: 24JBV026; 16) DYNJ67875, UDI-DI: 10193489448825(each), 40193489448826(case), Lot Number: 24JBW137; 17) DYNJ17004L, UDI-DI: 10193489244144(each), 40193489244145(case), Lot Number: 24JBX679; 18) DYNJ47859C, UDI-DI: 10193489916065(each), 40193489916066(case), Lot Number: 24KBA576; 19) SYNJ10259A, UDI-DI: 10193489786873(each), 40193489786874(case), Lot Number: 24KBB063; 20) DYNJ45667C, UDI-DI: 10193489991062(each), 40193489991063(case), Lot Number: 24KBC142; 21) DYNJ81548B, UDI-DI: 10198459100277(each), 40198459100278(case), Lot Number: 24KBC156; 22) DYNJ50653F, UDI-DI: 10195327653149(each), 40195327653140(case), Lot Number: 24KBD242; 23) DYNJ41097A, UDI-DI: 10888277213487(each), 40888277213488(case), Lot Number: 24KBD377; 24) DYNJ60631B, UDI-DI: 10193489994421(each), 40193489994422(case), Lot Number: 24KBF041; 25) DYNJ44061, UDI-DI: 10888277081994(each), 40888277081995(case), Lot Number: 24KBF076; 26) DYNJ44544F, UDI-DI: 10198459122804(each), 40198459122805(case), Lot Number: 24KBF265; 27) DYNJ49515D, UDI-DI: 10193489508024(each), 40193489508025(case), Lot Number: 24KBH120; 28) DYNJ35438F, UDI-DI: 10193489612028(each), 40193489612029(case), Lot Number: 24KBH238; 29) DYNJ55208A, UDI-DI: 10193489967593(each), 40193489967594(case), Lot Number: 24KBH297; 30) DYNJ81534B, UDI-DI: 10198459082917(each), 40198459082918(case), Lot Number: 24KBH549; 31) DYNJ49515D, UDI-DI: 10193489508024(each), 40193489508025(case), Lot Number: 24KBI136
• Recalling Firm/ Manufacturer: MEDLINE INDUSTRIES, LP - Northfield; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Haley Barclay; 866-359-1704
• Manufacturer Reason for Recall: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
• FDA Determined Cause: Under Investigation by firm
• Action: An IMMEDIATE ACTION REQUIRED MEDLINE DEVICE RECALL notification letter dated 3/3/25 was sent to customers. REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. 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 response form. 3.Please destroy any affected inventory. Medline will issue credit for the product based upon the quantity and lot numbers identified on the submitted response form The login for completing the response form is: Website link: https://recalls.medline.com Recall Reference #: R-25-050-FG Recall Code: RECALL CODE 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 request that customers document and destroy any affected product, and include your customer s quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
• Quantity in Commerce: 3909 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.
• 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.