Recall Z-2543-2021— Vascutek, Ltd.
Class II · Terminated
Class II FDA medical device recall by Vascutek, Ltd., initiated 2021-07-08, terminated 2024-08-19. It names 2 FDA 510(k) clearances: K972201, K963611. Product: The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t. Reason: The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees..
- Recalling firm
- Vascutek, Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-07-08
- Terminated
- 2024-08-19
- Firm location
- Inchinnan, N/A, United Kingdom
510(k) clearances named in this recall
2 on FDA's record- K972201 — PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE
- K963611 — VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t
Reason for recall
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
Data sourced from openFDA. This site is unofficial and independent of the FDA.