Recall Z-2332-2023— 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. 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: 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. 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.