CLASS II ONGOING Device recall · Reported 9 Aug 2023 · FDA Enforcement Report
Gore Tips Set Device recalled by Creganna Medical Devices
Creganna Medical Devices is recalling Gore Tips Set Device, distributed nationwide in the US. The recall was initiated on 22 Jun 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2249-2023
- FDA event ID
- 92608
- Recalling firm
- Creganna Medical Devices, Galway, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Jun 2023
- FDA classified
- 28 Jul 2023
- Reported
- 9 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 22 Jun 2023 | Recall initiated by company | |
| 28 Jul 2023 | Classified by FDA | +36 days |
| 9 Aug 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Three lots of product may be labeled with an incorrect expiration day
Product as listed by the FDA
Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
Where it was distributed
US Nationwide distribution in the state of AZ.
Questions about this recall
Is Gore Tips Set Device recalled?
Yes. Creganna Medical Devices recalled Gore Tips Set Device on 22 Jun 2023. The recall is Class II and its status is Ongoing. Recall number Z-2249-2023.
Why was it recalled?
Three lots of product may be labeled with an incorrect expiration day
Which lots are affected?
UDI/DI 05391526210000, Lot Numbers: 1V00099635, 1V00166928, 1V00199622
Where was it sold?
US Nationwide distribution in the state of AZ.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Creganna Medical Devices
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Boston Scientific Zurpaz(TM) Medium Curl, Asymmetric Curve recalled | Creganna Medical Devices | Sterility | MA |
| Device | CLASS II | Boston Scientific Zurpaz(TM) Medium Curl, Symmetric Curve recalled | Creganna Medical Devices | Sterility | MA |
| Device | CLASS II | Boston Scientific Zurpaz(TM) Medium Curl, Asymmetric Curve recalled | Creganna Medical Devices | Sterility | MA |
| Device | CLASS II | Boston Scientific Zurpaz(TM) Medium Curl, Asymmetric Curve recalled | Creganna Medical Devices | Sterility | MA |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |