Recall Z-2536-2023
Advance Medical Designs, Inc. · initiated July 7, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b) 28-EG125, c) 28-EG135, d) 28-EG151, e) 28-EG161, f) 28-EG163, g) 28-EG197
Codes / lots: a) 28-EG103, Lot Numbers: 10717C1190; b) 28-EG125, Lot Numbers: 30552C3318; c) 28-EG135, Lot Numbers: 10634C1175, 220221C2163; d) 28-EG151, Lot Numbers: 20655C2250, 20814C2279; e) 28-EG161, Lot Numbers: 10759C1198; f) 28-EG163, Lot Numbers: 10614C1166; g) 28-EG197, Lot Numbers: 10710C1190, 20804C2274;
Reason for recall
Ultrasound gel mislabeled with inappropriate use.
FDA-determined cause: Other
Action taken
Advance Medical Designs issued an URGENT MEDICAL DEVICE RECALL notice on 07/27/2023 by email and USPS, first class. The notice explained the problem, hazard, and requested the consignee locate, isolate, and cease all use of the affected products. Distributors were directed to notify their customers. Advance Medical Designs is seeking the return of the affected products.
Details
- Recall number
- Z-2536-2023
- Initiated
- July 7, 2023
- Posted by FDA
- September 9, 2023
- Product code
- GDF – Guide, Needle, Surgical
- Quantity
- 460 units
- Distribution
- US, Canada, UK, Panama, Netherlands
- Recalling firm
- Advance Medical Designs, Inc., Marietta, GA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2532-2023 Class II | ASG-001; Ultrasound gelUltrasound gel mislabeled with inappropriate use. | 07/07/2023Open, Classified |
| Z-2533-2023 Class II | 50-GEL20; Ultrasound gelUltrasound gel mislabeled with inappropriate use. | 07/07/2023Open, Classified |
| Z-2534-2023 Class II | Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b)…Ultrasound gel mislabeled with inappropriate use. | 07/07/2023Open, Classified |
| Z-2535-2023 Class II | Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b)…Ultrasound gel mislabeled with inappropriate use. | 07/07/2023Open, Classified |
| Z-2537-2023 Class II | procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-GG023, b)…Ultrasound gel mislabeled with inappropriate use. | 07/07/2023Open, Classified |