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U.S. Department of Health and Human Services

Class 2 Device Recall FLIXENE Graft

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 Class 2 Device Recall FLIXENE Graftsee related information
Date Initiated by FirmMay 03, 2024
Date PostedJune 04, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2013-2024
Recall Event ID 94614
510(K)NumberK060124 K071923 
Product Classification Prosthesis, vascular graft, of 6mm and greater diameter - Product Code DSY
ProductFLIXENE, 4-7X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
Code Information Product Code: 25129; UDI-DI: 00650862251296.
Recalling Firm/
Manufacturer		 Atrium Medical Corporation
40 Continental Blvd
Merrimack NH 03054-4332
For Additional Information ContactJosephine McBride
973-709-6929
Manufacturer 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.
FDA Determined
Cause 2		Equipment maintenance
ActionConsignees 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 GDSgrafts2024@getinge.com 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 Commerce53,308 units (US: 11, 236; OUS: 42,072)
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DSY
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