—#201477

Product

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK SUPPLIES NDL CNTR, Model Number DYNJRA1755; b) VNUS TEST KIT CFP-LF, Model Number DYNJTESTCFP4; c) ULTRASOUND PIV BUNDLE, Model Number IV8635D; d) ULTRASOUND GUIDED PIV KIT, Model Number IVS3300; e) ULTRASOUND GUIDED PIV INSERTIO, Model Number IVS3485A; f) EPIV PROCEDURE TRAY, Model Number IVS3825; g) ULTRASOUND GUIDED PIV INSERTIO, Model Number IVS3840A; h) RADIOLOGY TRAY, Model Number MNS11625; i) BEDSIDE PROCEDURE PREP KIT, Model Number MNS7695A; j) NGHS EVOR ANGIO PACK, Model Number NG410A; k) PICC INSERT KIT-LESS THAN 3 FR, Model Number PHS41739A; l) RADIOLOGY SPECIALS PACK, Model Number PHS479840M; m) HYBRID OR PACK, Model Number SYNJ10303B; n) TVS4500 MULTI PURPOSE VEIN, Model Number TVS4500A; o) TVS4500 MULTI PURPOSE VEIN, Model Number TVS4500B; p) VC PROCEDURE KIT, Model Number VC-PK

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNJRA1755, UDI/DI (EA) 10193489842845, UDI/DI (CS) 40193489842846; b) Model Number DYNJTESTCFP4, UDI/DI (EA) 10193489472813, UDI/DI (CS) 40193489472814; c) Model Number IV8635D, UDI/DI (EA) 10653160990260, UDI/DI (CS) 40653160990261; d) Model Number IVS3300, UDI/DI (EA) 10653160307662, UDI/DI (CS) 40653160307663; e) Model Number IVS3485A, UDI/DI (EA) 10653160990154, UDI/DI (CS) 40653160990155; f) Model Number IVS3825, UDI/DI (EA) 10653160330752, UDI/DI (CS) 40653160330753; g) Model Number IVS3840A, UDI/DI (EA) 10193489476736, UDI/DI (CS) 40193489476737; h) Model Number MNS11625, UDI/DI (EA) 10653160322139, UDI/DI (CS) 40653160322130; i) Model Number MNS7695A, UDI/DI (EA) 10653160343455, UDI/DI (CS) 40653160343456; j) Model Number NG410A, UDI/DI (EA) 10889942945887, UDI/DI (CS) 40889942945888; k) Model Number PHS41739A, UDI/DI (EA) 10889942906802, UDI/DI (CS) 40889942906803; l) Model Number PHS479840M, UDI/DI (EA) 10193489682724, UDI/DI (CS) 40193489682725; m) Model Number SYNJ10303B, UDI/DI (EA) 10193489373745, UDI/DI (CS) 40193489373746; n) Model Number TVS4500A, UDI/DI (EA) 10816982023374, UDI/DI (CS) 40816982023375; o) Model Number TVS4500B, UDI/DI (EA) 10195327223564, UDI/DI (CS) 40195327223565; p) Model Number VC-PK, UDI/DI (EA) 10195327176891, UDI/DI (CS) 40195327176892;

Why it was recalled

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Root cause (FDA determination)

Device Design

Action the firm took

Medline distributed their recall notices to their consignees beginning on 05/18/2023 by letter. The notices explained the problem, and the risk and requested the destruction of the products. Distributors were directed to notify their consignees, have the customers document and destroy any affected product, and include your customers quantities on the response form. Beginning on 05/23/2023, Medline issued another notice to a separate group of consignees requesting that the kits be over labeled. Distributors were directed to notify the customers and have them return any affected product to the distributor for collection and return to Medline. Questions: please contact the Recall Department at 866-359-1704

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

Timeline

Recall initiated: 2023-05-18
Posted by FDA: 2023-07-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #201477. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.