MEDLINE INDUSTRIES, LP - Northfield recalls Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Nu

Recalled July 26, 2023 · FDA recall Z-2169-2023 · MEDLINE INDUSTRIES, LP - Northfield

Hazard

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

Units

770147 units

Sold at

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

Description

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

Product

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214Q; b) MINOR PROCEDURE TRAY, Model Number DYNDA2418; c) CLOSUREFAST PROCEDURE PACK-LF, Model Number DYNJ0365463J; d) BARIATRIC PACK, Model Number DYNJ24459P; e) ABLATION PACK, Model Number DYNJ40629B; f) ENDOLUMINAL ACCESSORY PACK, Model Number DYNJ44210B; g) IR THYROID PACK (THLUF)642-LF, Model Number DYNJ47716C; h) EVLT SURGICAL PACK, Model Number DYNJ48520; i) MAXIMAL BARRIER BEDSIDE PACK, Model Number DYNJ53059A; j) LAPAROSCOPY PACK, Model Number DYNJ59813; k) PORT PACK, Model Number DYNJ61747C; l) RR-BRACHY PACK, Model Number DYNJ68027A; m) AV FISTULA PACK, Model Number DYNJ81410B; n) ECMO PACK-LF, Model Number DYNJ82517; o) SYNERGY PROCEDURE PACK, Model Number DYNJ83966; p) MINOR, Model Number DYNJ906915; q) PROCEDURE PACK DR BILIMORI, Model Number DYNJ908046C; r) ULTRASOUND PACK-LF, Model Number PHS751646C; s) ULTRASOUND PACK-LF, Model Number PHS751646D;

Manufacturer(s)

MEDLINE INDUSTRIES, LP - Northfield

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →