Recall Z-2196-2023— 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) VNUS TRAY, Model Number DYNJ44410G; b) INTRAUTERINE TRNSFUSION -LF, Model Number DYNJ9048708I; c) PERI NEURO BLOCK PACK-LF, Model Number PHS762887001B; d) TVS4700 CUSTOM PACK, Model Number TVS4700;. 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) VNUS TRAY, Model Number DYNJ44410G; b) INTRAUTERINE TRNSFUSION -LF, Model Number DYNJ9048708I; c) PERI NEURO BLOCK PACK-LF, Model Number PHS762887001B; d) TVS4700 CUSTOM PACK, Model Number TVS4700;
Reason for recall
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Data sourced from openFDA. This site is unofficial and independent of the FDA.