Advance Medical Designs, Inc. Recall 92735
Description: Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04
Advance Medical Designs, Inc. Recall 92735 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2534-2023 |
| Event ID | 92735 |
| Event Description | Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04 |
| Product Type | Devices |
| Distribution | US, Canada, UK, Panama, Netherlands |
| Quantity | 26900 units |
| Recall Reason | Ultrasound gel mislabeled with inappropriate use. |
| Device Classification | 20230920 |
| Device Code Info | a) 20-PMT03, Lot Numbers: 30479C3299 b) 20-PMT04, Lot Numbers: 30394C3279 |
| Center Classification Date | 20230908 |
| Recall Initiation Date | 20230707 |
| Recalling Firm | Advance Medical Designs, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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