Recall Z-0171-2022— W L Gore & Associates, Inc.
Class II · Ongoing
Class II FDA medical device recall by W L Gore & Associates, Inc., initiated 2021-09-02. FDA's recall record names no specific 510(k) clearance for this event. Product: REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620128 *Not distributed within the US. Reason: Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs..
- Recalling firm
- W L Gore & Associates, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-09-02
- Firm location
- Flagstaff, AZ, United States
Product description
REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620128 *Not distributed within the US
Reason for recall
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Data sourced from openFDA. This site is unofficial and independent of the FDA.