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FLIXENE SLIDER GDS recallZ-2002-2024 · Atrium Medical Corporation · initiated May 3, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Atrium Medical Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.

FDA root cause category: Equipment maintenance

What the company is doing

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.

Recall details

Recall number
Z-2002-2024
Status
Open, Classified
Initiated by the company
May 3, 2024
Posted by the FDA
Jun 4, 2024
Recalling firm
Atrium Medical Corporation
Quantity
53,308 units (US: 11, 236; OUS: 42,072)
Product code
DSY
FDA submissions
K060124, K071923
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 description

FLIXENE, 6X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft

Code information (models, lots, serial numbers)

Product Code: 25058; UDI-DI: 00650862250589.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

1 device cleared under K060124, K071923 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 94614).

Sources and updates

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