FDAFDA · Food and drugs·Recall number Z-2336-2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. EGG RETRIEVAL PACK, Model Number: DYNJ66291B; b. FETAL SURGERY CDS-LF, Model Number: CDS840214P; c. TVT PACK SMGH-LF, Model Number: DYNJ41913C;
Published August 9, 2023 · Recall initiated: May 15, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
- Lot
- All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ66291B, UPC Number: 019532715117. b. Model Number: CDS840214P, UPC Number: 019348944319. c. Model Number: DYNJ41913C, UPC Number: 019348967757.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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