Z-2332-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 9, 2023
- Initiation Date
- May 15, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,319 kits
Product Description
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 Pattern
Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
Code Information
All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ66041A, UPC Number: 019348948028; Model Number: DYNJ66041B, UPC Number: 019532715107. b. Model Number: DYNJ62319A, UPC Number: 019348947486; Model Number: DYNJ62319B, UPC Number: 019348999548. c. Model Number: DYNDV2397, UPC Number: 019348938846. d. Model Number: DYNJ24276C, UPC Number: 088438943118. e. Model Number: DYNJ27275, UPC Number: 008019683311.