MEDLINE INDUSTRIES, LP – Northfield Recall 92399
Description: 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;
MEDLINE INDUSTRIES, LP – Northfield Recall 92399 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2336-2023 |
| Event ID | 92399 |
| Event Description | 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; |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates. |
| Quantity | 211 kits |
| Recall Reason | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| Device Classification | 20230809 |
| Device Code Info | 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. |
| Center Classification Date | 20230803 |
| Recall Initiation Date | 20230515 |
| Recalling Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Initial Notification | Letter |
| Similar To |