—#207988

Product

Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack #ACC010254B, containing a Pure Pouch component DYND04000, O.R. Scissors S/B, 5.5 Sterile. b. Medline Code Cart Drawer 2 Adult Kit, Pack ACC010365A, containing a Pure Pouch component DYNJ04048, Kelly Forceps/STD STR Sterile. c. Medline Code Cart Drawer 2 Adlt Peds, Pack #ACC010366A, containing a Pure Pouch component DYNJ04048, Kelly Forceps/STD STR Sterile. d. Medline Drawer 2, Pack #ACC010375A, containing a Pure Pouch component Reorder #TRI67630, Sterile Straight Mayo Scissors, 5.5" and Sterile Magill Forceps, Reorder #66790. e. Medline Adult Drawer 4, Pack #ACC010389C, containing a Pure Pouch component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. f. Medline Code Cart Drawer 1 Adult Airwa, Pack #ACC010451A, containing a Pure Pouch component Sterile Magill Forceps, Reorder #66790. g. Medline Emergency Airway Drawer, Pack #ACC010492, containing a Pure Pouch component Sterile Magill Forceps, Reorder #66790. h. Medline Drawer 2, Pack #ACC010681, containing a Pure Pouch component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile and Sterile Magill Forceps, Reorder #66790. i. Medline Drawer 2, Pack #ACC010690, containing a Pure Pouch component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. j. Medline Drawer Two #IMF 109694, Pack #ACCVB1000A, containing a Pure Pouch component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. k. Medline First Hlth Moore Bronchoscopy, Pack #DYK1015098B4, containing a Pure Pouch component DYND04000, O.R. Scissors S/B, 5.5 Sterile. l. Medline Trunk Kit 1EA, Pack #DYKM2013A, containing a Pure Pouch component #DYNJ04048, Kelly Forceps/STD STR Sterile. m. Medline Difficult Kit, Pack #DYKM2135, containing a Pure Pouch component Sterile Curved Kelly Hemostat, Reorder #66175 and Sterile Magill Forceps, Reorder #66790. n. Medline Wound Care Kit, Pack #DYNDW1033B, containing a Pure Pouch component DYND04000, O.R. Scissors S/B, 5.5 Sterile.

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: a. Pack #ACC010254B - Lot numbers 23KDB117, exp. 11/3/2024, and 23GDC173, exp. 6/30/2024, UDI-DI each-10193489651683 and UDI-DI case-40193489651684. b. Pack ACC010365A - Lot number23EDA386, exp. 12/31/2024, UDI-DI each 10195327063245 and UDI-DI case-40195327063246. c. Pack #ACC010366A - Lot number 23EDB861, exp. 1/31/2024, UDI-DI each 10195327063252 and UDI-DI case 40195327063253. d. Pack #ACC010375A - Lot numbers 23LDB985, exp. 6/30/2025; 23HDB243, exp. 3/31/2024, UDI-DI each-10193489890983 and UDI-DI case-40193489890984. e. Pack #ACC010389C - Lot numbers 24ADB277, exp. 3/31/2025; 23LDA035, exp. 3/31/2025; and 23HDC448, exp. 6/30/2024, UDI-DI each 10193489472493 and UDI-DI case-40193489472494. f. Pack #ACC010451A - Lot number 23HDB718, exp. 3/31/2025, UDI-DI each 10193489844849 and UDI-DI case 40193489844840. g. Pack #ACC010492 - Lot numbers 23IDA433, exp. 6/30/2024; 23HDC689, exp. 6/30/2024; and 23HDA419, exp. 5/30/2024; UDI-DI each-10193489481983 and UDI-DI case 40193489481984. h. Pack #ACC010681 - Lot numbers 24ADA608, exp. 7/31/2025; and 23HDB308, exp. 6/30/2025, UDI-DI each 10195327399665 and UDI-DI case-40195327399666. i. Pack #ACC010690 - Lot number 23IDB053, exp. 6/30/2024, UDI-DI each 10195327433307 and UDI-DI case-40195327433308. j. Pack #ACCVB1000A - Lot numbers 24ADB906, exp. 12/31/2024; 23KDC115, exp. 2/28/2025; 23IDB740, exp. 6/30/2024; and 23EDA442, ex. 5/31/2024; UDI-DI each-10195327345884 and UDI-DI case-40195327345885. k. Pack #DYK1015098B4 - Lot numbers 23IBA570, exp. 8/31/2026, and 23GBP526, exp. 8/31/2026, UDI-DI each 10884389250853 and UDI-DI case 40884389250854. l. Pack #DYKM2013A - Lot numbers 23KBH011, 23IBJ540, 23HBP844, 23HBE308, 23GBT102, and 23FBS539, all with exp. dates of 7/31/2024, UDI-DI each-10195327419868 and UDI-DI case-40195327419869. m. Pack #DYKM2135 - Lot numbers 24ABP810, 23EBJ055, and 23DBH351, all with exp. dates of 8/31/2025, UDI-DI each-10195327075798 and UDI-DI case-40195327075799. n. Pack #DYNDW1033B - Lot numbers 23LME845, exp. 4/30/2025; 23KMD933, exp. 4/30/2025, and 23GMF688, exp. 1/31/2025, UDI-DI each-10888277079182 and UDI-DI case-40888277079183.

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 #207988. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.