Septal Occluder Devices Recalled for Incorrect Expiration Date Label
W L Gore & Associates is recalling 222 GORE Cardioform Septal Occluder devices labeled with a 3-year expiration date instead of the correct 2-year expiration.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Expiration date mislabeling on an FDA Class II medical device creates potential risk of use beyond actual product expiration, though no injuries or illnesses have been reported.
Plain-English summary
W L Gore & Associates, Inc. is recalling 222 units of the GORE Cardioform Septal Occluder (Catalogue Number GSXE0030B, UDI: 00733132620128) due to labeling error. The affected devices are labeled with a 3-year expiration date instead of the correct 2-year expiration period.
The recalled devices were distributed throughout the United States and to multiple countries including Australia, Austria, Canada, Switzerland, Germany, Denmark, Spain, France, United Kingdom, Greece, Ireland, Italy, Mexico, Netherlands, Norway, Portugal, Saudi Arabia, and Sweden. Affected units can be identified by serial numbers 22689696 through 23569078.
Incorrect expiration date labeling poses a risk of device use beyond the actual expiration date. Healthcare providers should immediately stop using affected devices and contact W L Gore & Associates for replacement or additional information.
The recalled product
- 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
- Manufacturer
- W L Gore & Associates, Inc.
- Category
- Medical Device — Septal Occluder
- Hazard
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- serial numbers 22689696 through 23569078
Distribution
Distributed in 47 states:
- 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
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