Recall Z-0172-2022 ยท MLV Transcatheter Septal Occluder
W L Gore & Associates, Inc.
REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132648948 *Not distributed within the US
| Date | Sep 2, 2021 |
| Status | Open, Classified |
| Reason | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs. |
| Root cause | Software change control |
| Action | Gore initiated distribution of "Urgent Medical Device Recall" Notification to affected consignees between the dates of September 2, 2021 - September 21, 2021. The customer communication was distributed via Email and UPS. In addition, to informing consignees about the recall, Gore asked consignees to take the following actions: 1. Identify and return any unused devices within the scope of this voluntary recall. Return Authorization number can be found on the CUSTOMER RESPONSE FORM. 2. Please complete and sign the enclosed CUSTOMER RESPONSE FORM and return to WLGore3120@sedgwick.com within 3 w |
| Quantity | 15 units |
| Distribution | US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ, NM,NV,NY,OH,OK,OR,PA,SC,SD,TN,TX,UT,VA,VT,WA,WI, WV OUS: AUS, AUT, CAN, CHE, DEU, DNK, ESP, FRA, GBR, GRC, IRL, ITA, MEX, NLD, NOR, PRT, SAU, SWE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.