FDA recall Z-2183-2023

Product

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) IV SECUREMENT KIT, Model Number DYNDV2407A; b) USG IV START KIT, Model Number DYNDV2435; c) ULTRASOUND GUIDED IV START KIT, Model Number DYNDV2518; d) VI PACK, Model Number DYNJ64871

Reason for recall

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

Distribution

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

Key facts

Status

Ongoing

Initiation date

2023-05-18

Report date

2023-07-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2183-2023