FDA recall Z-2332-2023

Product

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. FETAL INTERVENTION, Model Number: DYNJ66041A, DYNJ66041B; b. FETAL INTERVENTION PACK, Model Number: DYNJ62319A, DYNJ62319B; c. ULTRASOUND PIV KIT, Model Number: DYNDV2397; d. VAD ACCESS, Model Number: DYNJ24276C; e. VAGINAL DELIVERY TRAY, Model Number: DYNJ27275

Reason for recall

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

Key facts

Status

Ongoing

Initiation date

2023-05-15

Report date

2023-08-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2332-2023