FLIXENE, 7X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
Reported: June 12, 2024 Initiated: May 3, 2024 #Z-2005-2024
Product Description
FLIXENE, 7X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
Reason for Recall
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Details
- Recalling Firm
- Atrium Medical Corporation
- Units Affected
- 53,308 units (US: 11, 236; OUS: 42,072)
- Distribution
- Worldwide distribution - US Nationwide including Puerto Rico, and the countries of AE, AR, AT, AU, BE, BG, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, ID, IE, IL, IQ, IT, JO, JP, KR, KW, LT, LU, LV, ME, MN, MU, MX, MY, NI, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, RO, RU, SA, SE, SG, SI, SV, TH, TN, TR, TW, UA, VN, XK, YE, ZA.
- Location
- Merrimack, NH
Frequently Asked Questions
What product was recalled? ▼
FLIXENE, 7X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft. Recalled by Atrium Medical Corporation. Units affected: 53,308 units (US: 11, 236; OUS: 42,072).
Why was this product recalled? ▼
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 12, 2024. Severity: Moderate. Recall number: Z-2005-2024.
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