FDA recall Z-2184-2023

Product

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) LACERATION TRAY, Model Number DYNDL1134A; b) ULTRASOUND GUIDED IV/MIDLINE K, Model Number DYNDV2385; c) PEDIATRIC CENTRAL LINE KIT, Model Number DYNJ38885B; d) CENTRAL LINE TRAY, Model Number DYNJ42902B; e) CENTRAL LINE PACK - COMPANION, Model Number DYNJ47215D; f) PICC LINEPACK (PCLUI)642-LF, Model Number DYNJ47717A; g) PK CUST CENTRAL LINE PACK, Model Number DYNJ60586; h) TUNNEL LINE PACK, Model Number DYNJ67990; i) CLOSURE PACK, Model Number DYNJ83054A

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-2184-2023