Recall Z-2316-2023— MEDLINE INDUSTRIES, LP - Northfield
Class II · Ongoing
Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2023-05-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC PACK, Model Number: DYNJ46967F; b. ENDOVENOUS ABLATION PACK, Model Number: DYNJ64059; c. ENDOVENOUS CORE PACK: DYNJ62557; d. TVS4000 ENDOVENOUS PACK, Model Number: TVS4000K. Reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications..
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-05-15
- Firm location
- Northfield, IL, United States
Product description
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC PACK, Model Number: DYNJ46967F; b. ENDOVENOUS ABLATION PACK, Model Number: DYNJ64059; c. ENDOVENOUS CORE PACK: DYNJ62557; d. TVS4000 ENDOVENOUS PACK, Model Number: TVS4000K
Reason for recall
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Data sourced from openFDA. This site is unofficial and independent of the FDA.