RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX
FDA device recall Z-0997-2023 · posted 2023-01-19 · Open, Classified
Recall details
- Recalling firm
- Bolton Medical Inc.
- Reason for recall
- The product may be shorter than packaging indicates
- Action taken
- On 12/15/2022, Terumo Aortic/Bolton Medical, Inc. issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees by mail. The notice explained the problem and the risk, and requested the return of the device to a Terumo Sales Representative.
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- MIH
- Quantity affected
- 129 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of UK, France, Germany, Italy, Netherlands, Chile, Japan, and China.
- Date initiated
- 2022-12-20
- Date posted
- 2023-01-19
- Location
- Sunrise, FL
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