—#207980

Product

Nonsterile convenience kits: a. Medline Delivery, Pack #DYNJ901130I, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissors, S/B, 5.5 Sterile. b. Medline C-Section, Pack DYNJ902938J, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissors, S/B, 5.5 Sterile.

FDA product code: MLS — Labor And Delivery Kit
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
Affected lot / code info: a. Pack #DYNJ901130I - Lot numbers 23GMH075, exp. 7/31/2024, and 23GMD605, exp. 7/31/2024, UDI-DI each-10193489946055 and UDI-DI case-40193489946056. b. Pack DYNJ902938J - Lot numbers 23LMD530, 23IMG375, 23HMB336, 23GMF342, 23EMJ935, and 23EMK254, all exp. date 8/31/2024, UDI-DI each-10193489946116, UDI-DI case 40193489946117.

Why it was recalled

Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.

Root cause (FDA determination)

Process control

Action the firm took

The recalling firm issued two different letters on and dated 3/14/2024 via first class mail and email. One of the letters was for the recall of the non-sterile kits and the other letter was flagged as a Safety Alert for the sterile kits. The recall letter for the non-sterile kits explained the issue of the Pure Pouches (which is the packaging for a sterile component) contained within the kits have been found to have weak seals which may not be detectable to the user. This would result in a breach of sterility of the component within the Pure Pouch. The hazard of the sterility breach was explained and required actions were listed which were: (1) Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal and quarantine all affected product immediately; (2) Use the login link and the information in the letter to complete the response form. List the quantity of affected product in inventory on the form, regardless of whether or not it is in inventory, and submit the form; (3) Upon receipt of the response form, the account will receive over-labels to place on affected inventory with instructions for the staff to remove the affected component prior to using the kit. The labels will be provided via FedEx overnight; and (4) If the account is a distributor or has resold or transferred this product to another company or individual, the account is to notify them of this recall communication. The letter regarding the sterile kits was flagged as a safety alert and explained the issue of the Pure Pouches contained within the kits have weak seals. The letter went onto say that despite the Pure Pouch having a weak seal, the kit lots were sterilized in a Medline-validated ethylene oxide (EO) process that renders the component(s) within the Pure Pouch sterile. Medline stated they are issuing this safety alert to reiterate that the kit is single-use only. In the event the affected components are not

Recalling firm

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

Distribution

Distribution pattern: US Nationwide distribution in the states of AL, CA, CO, CT, FL, IL, IN, MD, MN, MT, NC, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, and WY.

Timeline

Recall initiated: 2024-03-14
Posted by FDA: 2024-06-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #207980. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.