Recall Z-2169-2023— MEDLINE INDUSTRIES, LP - Northfield
Class II · Ongoing
Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2023-05-18. FDA's recall record names no specific 510(k) clearance for this event. 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;. Reason: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams..
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-05-18
- Firm location
- Northfield, IL, United States
Product description
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;
Reason for recall
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
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