REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery P
Summary
The FDA issued a Class II for REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, C by W L Gore & Associates, Inc.. Reason: Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs..
Details
Source
Device Recall
External ID
Z-0168-2022
Action Date
2021-11-03
Status
Ongoing
Category
device
Product Description
REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617647 *Not distributed within the US
Lot/Code Info: serial numbers 22689696 through 23569078
Quantity Affected: 1268 unit
Reason for Recall
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-02
Company
Flagstaff, AZ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 124 device recalls issued in the same week, part of 403 device-related FDA actions this month.
W L Gore & Associates, Inc. has 25 FDA actions in our database, including 20 recalls and 5 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (W L Gore & Associates, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does W L Gore & Associates, Inc. have FDA actions?
W L Gore & Associates, Inc. has 25 FDA actions in our database, including 20 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0168-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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