Z-2015-2024Class II
FLIXENE, 4-7X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft
Atrium Medical Corporation / initiated 2024-05-03 / Open, Classified / root cause: manufacturing process
Atrium Medical Corporation began a recall of FLIXENE, 4-7X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft on . FDA classified it as Class II and gives the reason as "Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2015-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Atrium Medical Corporation
- Product
- FLIXENE, 4-7X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft
- Product code
- DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
- 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.
- Root cause tag
- manufacturing process
- FDA root cause
- Equipment maintenance
- Action
- Consignees were sent an URGENT MEDICAL DEVICE- REMOVAL notification by mail, dated 5/3/24. Consignees are instructed to examine their inventory immediately to determine if any recalled product is in their possession. Recalled product possesses the REF number on device labeling and has an expiration date prior to 24FEB2027. All consignees are asked to complete and return the provided response form by email to [email protected] or by fax to 1-866-560-4062. Consignees that are distributors are asked to forward the provided notification to their customers. Consignees are to post a copy of the recall notification in all inventory locations where affected devices are stored and ensure all appropriate personnel are aware. If consignees possess recalled devices, they are to contact their local Atrium/Getinge Customer Support Department at 888-943-8872 (option 2) to receive instructions for returning any affected devices. The recalling firm will provide replacement product within 5-8 weeks of return of devices. The recalling firm states that if there is a medical need to use the device and no alterative device is available, then the graft may be used per the provided instructions. Customers can contact Customer support with any questions at 888-943-8872 (option 2) from Monday through Friday, between 8:00 AM and 6:00 PM.
- Quantity in commerce
- 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.
- Product codes and lots
- Product Code: 25135; UDI-DI: 00650862251357.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1951-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1952-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1953-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1954-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1955-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1956-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1957-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1958-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1959-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1960-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1961-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1962-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1963-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1964-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1965-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1966-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1967-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1968-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1969-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1970-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1971-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1972-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1973-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1974-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1975-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1976-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1977-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1978-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1979-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1980-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1981-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1982-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1983-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1984-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1985-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1986-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1987-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1988-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1989-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1990-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1991-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1992-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1993-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1994-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1995-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1996-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1997-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1998-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1999-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2000-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2001-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2002-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2003-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2004-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2005-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2006-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2007-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2008-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2009-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2010-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2011-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2012-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2013-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2014-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2015-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2016-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2017-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2018-2024 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.