—#201489

Product

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ0429121G; b) DBS PACK-LF, Model Number DYNJ0878178J; c) DBS PACK-LF, Model Number DYNJ0878178K; d) NEURO ARTERIOGRAM PACK-LF, Model Number DYNJ0948060F; e) NEURO IR PACK, Model Number DYNJ35066I; f) NEURO IR PACK, Model Number DYNJ35066J; g) IR NEURO PACK, Model Number DYNJ39198L; h) IR NEURO PACK, Model Number DYNJ39198N; i) BASIC PACK, Model Number DYNJ39752A; j) C.I.C.N. ANGIO PACK, Model Number DYNJ53064B; k) ANGIOGRAPHIC PACK, Model Number DYNJ57442C; l) ANGIO/VENO PACK, Model Number DYNJ58346A; m) NEURO RADIOLOGY PACK, Model Number DYNJ59903A; n) NEURO RADIOLOGY PACK, Model Number DYNJ59903B; o) PACK PERCUTANEOUS ANGIO CHRG, Model Number DYNJ60112A; p) NEURO IR PACK, Model Number DYNJ60701D; q) RADIOLOGY NEURO DRAPE PAC, Model Number DYNJ61449; r) NEURO PACK, Model Number DYNJ61798D; s) BASIC CATH/ANGIO, Model Number DYNJ62591A; t) ANGIOGRAPHIC PACK, Model Number DYNJ64081A; u) ANGIO PACK, Model Number DYNJ64676; v) ANGIOGRAPHY PACK, Model Number DYNJ65963; w) NEURO PACK, Model Number DYNJ66241A; x) NEURO PACK, Model Number DYNJ66241B; y) NEURO PACK, Model Number DYNJ66241C; z) NEURO PACK, Model Number DYNJ66241D; aa) NEURO ACCESSORY PACK, Model Number DYNJ66790A; bb) NEURO ACCESSORY PACK, Model Number DYNJ66790B; cc) NEURO TRAY, Model Number DYNJ67075A; dd) NEURO PACK, Model Number DYNJ68956A; ee) NEURO PACK, Model Number DYNJ68956B; ff) NEURO CATH PACK, Model Number DYNJ69129; gg) NEURO CATH PACK, Model Number DYNJ83090; hh) ANGIO, Model Number DYNJ905151A; ii) KIT OR AORTOGRM ANGIOPLAST PHT, Model Number DYNJ906086A; jj) ARTHROGRAM TRAY, Model Number SPEC0232

FDA product code: OJG — Neurological Tray
Device class: Class 1
Medical specialty: Neurology
Affected lot / code info: all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNJ0429121G, UDI/DI (EA) 10193489711554, UDI/DI (CS) 40193489711555; b) Model Number DYNJ0878178J, UDI/DI (EA) 10193489914368, UDI/DI (CS) 40193489914369; c) Model Number DYNJ0878178K, UDI/DI (EA) 10195327328788, UDI/DI (CS) 40195327328789; d) Model Number DYNJ0948060F, UDI/DI (EA) 10889942825103, UDI/DI (CS) 40889942825104; e) Model Number DYNJ35066I, UDI/DI (EA) 10193489262292, UDI/DI (CS) 40193489262293; f) Model Number DYNJ35066J, UDI/DI (EA) 10195327091071, UDI/DI (CS) 40195327091072; g) Model Number DYNJ39198L, UDI/DI (EA) 10193489262919, UDI/DI (CS) 40193489262910; h) Model Number DYNJ39198N, UDI/DI (EA) 10195327102005, UDI/DI (CS) 40195327102006; i) Model Number DYNJ39752A, UDI/DI (EA) 10884389907238, UDI/DI (CS) 40884389907239; j) Model Number DYNJ53064B, UDI/DI (EA) 10193489789164, UDI/DI (CS) 40193489789165; k) Model Number DYNJ57442C, UDI/DI (EA) 10193489208535, UDI/DI (CS) 40193489208536; l) Model Number DYNJ58346A, UDI/DI (EA) 10193489774634, UDI/DI (CS) 40193489774635; m) Model Number DYNJ59903A, UDI/DI (EA) 10195327042868, UDI/DI (CS) 40195327042869; n) Model Number DYNJ59903B, UDI/DI (EA) 10195327131203, UDI/DI (CS) 40195327131204; o) Model Number DYNJ60112A, UDI/DI (EA) 10193489247039, UDI/DI (CS) 40193489247030; p) Model Number DYNJ60701D, UDI/DI (EA) 10195327383312, UDI/DI (CS) 40195327383313; q) Model Number DYNJ61449, UDI/DI (EA) 10193489567342, UDI/DI (CS) 40193489567343; r) Model Number DYNJ61798D, UDI/DI (EA) 10193489992632, UDI/DI (CS) 40193489992633; s) Model Number DYNJ62591A, UDI/DI (EA) 10193489793314, UDI/DI (CS) 40193489793315; t) Model Number DYNJ64081A, UDI/DI (EA) 10193489273748, UDI/DI (CS) 40193489273749; u) Model Number DYNJ64676, UDI/DI (EA) 10193489214383, UDI/DI (CS) 40193489214384; v) Model Number DYNJ65963, UDI/DI (EA) 10193489307702, UDI/DI (CS) 40193489307703; w) Model Number DYNJ66241A, UDI/DI (EA) 10193489938036, UDI/DI (CS) 40193489938037; x) Model Number DYNJ66241B, UDI/DI (EA) 10195327053482, UDI/DI (CS) 40195327053483; y) Model Number DYNJ66241C, UDI/DI (EA) 10195327096854, UDI/DI (CS) 40195327096855; z) Model Number DYNJ66241D, UDI/DI (EA) 10195327138370, UDI/DI (CS) 40195327138371; aa) Model Number DYNJ66790A, UDI/DI (EA) 10193489922479, UDI/DI (CS) 40193489922470; bb) Model Number DYNJ66790B, UDI/DI (EA) 10195327099268, UDI/DI (CS) 40195327099269; cc) Model Number DYNJ67075A, UDI/DI (EA) 10195327054533, UDI/DI (CS) 40195327054534; dd) Model Number DYNJ68956A, UDI/DI (EA) 10193489876291, UDI/DI (CS) 40193489876292; ee) Model Number DYNJ68956B, UDI/DI (EA) 10195327094348, UDI/DI (CS) 40195327094349; ff) Model Number DYNJ69129, UDI/DI (EA) 10193489892413, UDI/DI (CS) 40193489892414; gg) Model Number DYNJ83090, UDI/DI (EA) 10195327230937, UDI/DI (CS) 40195327230938; hh) Model Number DYNJ905151A, UDI/DI (EA) 10193489813418, UDI/DI (CS) 40193489813419; ii) Model Number DYNJ906086A, UDI/DI (EA) 10193489208689, UDI/DI (CS) 40193489208680; jj) Model Number SPEC0232, UDI/DI (EA) 10888277507418, UDI/DI (CS) 40888277507419

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 #201489. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.