CLASS II Device recall · Reported 21 Jun 2017 · FDA Enforcement Report
Boston Scientific Zurpaz(TM) Medium Curl, Symmetric Curve recalled
Creganna Medical Devices is recalling Boston Scientific Zurpaz(TM) Medium Curl, Symmetric Curve, Steerable Sheath, 8.5F, distributed in Massachusetts. The recall was initiated on 22 May 2017 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-2530-2017
- FDA event ID
- 77406
- Recalling firm
- Creganna Medical Devices, Galway, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 May 2017
- FDA classified
- 13 Jun 2017
- Reported
- 21 Jun 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 22 May 2017 | Recall initiated by company | |
| 13 Jun 2017 | Classified by FDA | +22 days |
| 21 Jun 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of sterility assurance.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Boston Scientific Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USMC85100
Where it was distributed
Distributed in MA.
Questions about this recall
Why was it recalled?
Lack of sterility assurance.
Which lots are affected?
Lot # 383271, 384264
Where was it sold?
Distributed in MA.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 77406This product is part of a recall event; the main page for the event is Boston Scientific Zurpaz(TM) Medium Curl, Asymmetric Curve recalled.
More recalls from Creganna Medical Devices
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Gore Tips Set Device recalled by Creganna Medical Devices | Creganna Medical Devices | Other | Nationwide |
| 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 |
| 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 |