—#213076

Product

Medline Convenience kits used for various procedures: 1) PERI GYN PACK, Model Number: DYNJ80786; 2) D & C HYSTEROSCOPY PACK, Model Number: DYNJ21937J; 3) VAGINAL HYSTERECTOMY WRH-LF, Model Number: DYNJ41949B; 4) HYSTER/RESECTOSCOPE #78-RF, Model Number: DYNJ21824R; 5) PERI GYN, Model Number: DYNJ67708A; 6) HYSTEROSCOPY PACK, Model Number: DYNJ56417C; 7) HYSTEROSCOPY PACK CKHA-LF, Model Number: DYNJ51956B; 8) VAGINAL HYSTERECTOMY WRH-LF, Model Number: DYNJ41949B

FDA product code: OJF — Hysterectomy Kit
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
Affected lot / code info: 1) DYNJ80786, UDI-DI: 10195327079451(each), 40195327079452(case), Lot Number: 24IBH305; 2) DYNJ21937J, UDI-DI: 10195327694876(each), 40195327694877(case), Lot Number: 24JBN378; 3) DYNJ41949B, UDI-DI: 10195327128937(each), 40195327128938(case), Lot Number: 24JBT902; 4) DYNJ21824R, UDI-DI: 10195327107758(each), 40195327107759(case), Lot Number: 24JBU465; 5) DYNJ67708A, UDI-DI: 10195327039899(each), 40195327039890(case), Lot Number: 24JBV636; 6) DYNJ56417C, UDI-DI: 10195327468804(each), 40195327468805(case), Lot Number: 24KBB818; 7) DYNJ51956B, UDI-DI: 10889942599394(each), 40889942599395(case), Lot Number: 24KBC171; 8) DYNJ41949B, UDI-DI: 10195327128937(each), 40195327128938(case), Lot Number: 24KBC614

Why it was recalled

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

Timeline

Recall initiated: 2025-03-03
Posted by FDA: 2025-04-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #213076. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.