Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 (Marketed in U.S. only) Atriu
FDA device recall Z-2761-2017 · posted 2017-07-07 · Terminated
Recall details
- Recalling firm
- Atrium Medical Corporation
- Reason for recall
- Firm received a complaint that a customer who ordered an ADVANTA V12 7mm x 22mm x 120cm received an ADVANTA v12 7 mm x 38 mm x 80 cm, due to the manifold (catheter hub) was printed as 7mm x 38 mm x 80 cm. The complaint was the result of incorrect dimensional information (7mm x 38mm x 80cm) printed on the manifiold (catheter hub). The complaint device physical dimensions matched the dimensional information displayed on the outer packaging and the device inner pouch. This was the only complaint received for this non-conformance.
- Action taken
- The firm, Getinge/Maquet, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated May 25, 2017 via FedEx overnight to affected US consignees via FedEx Next Day Air. Getinge sent a second "URGENT MEDICAL DEVICE RECALL LETTER" dated June 2, 2017 via FedEx overnight to the affected customers in order to correct a product code/part number due to a typo in the initial letter and to assist in identifying the labeling problem. The letters described the product, problem and actions to be taken. Customers are instructed to examine your inventory; remove affected products; quarantine and place in a secure location; if you have the affected product, contact Getinge Customer Service at 1-603-880-1433, Monday through Friday between 9:00 am to 5:00 pm for RA and shipping instructions to return affected product to the Manufacturer, and complete and Return the enclosed Medical Device - Recall Response Form to email: catheterhub.us@getinge.com or fax to 1-973-807-9207. If you have any questions, please contact your Getinge/Maquet representative or call Maquet Customer Service at 1-603-880-1433, Monday through Friday between the hours of 9:00 am to 5:00 pm Eastern Time Zone.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- JCT
- Quantity affected
- 246 (US: 183 units; Foreign: 63 units)
- Distribution
- Worldwide distribution-US (nationwide) and countries of: Germany, Great Britain, Austria, Ireland, Netherlands, France, Italy, Sweden, and San Marino.
- Date initiated
- 2017-05-25
- Date posted
- 2017-07-07
- Date terminated
- 2020-06-26
- Location
- Hudson, NH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ATRIUM ICAST COVERED STENT (K050814) | Atrium Medical Corp. | 2005-05-06 |