Device evidence

device-recall:cfres:201464

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;

Official recall number

Z-2169-2023

Evidence summary

Product code: FDE
Recall status: Open, Classified
Event initiated: May 18, 2023
Root cause: Device Design
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-2169-2023