CLASS II Device recall · Reported 5 Nov 2014 · FDA Enforcement Report
Blunt Hurd Cannula Blunt Tip recalled by CooperSurgical, Inc. D.B.A.
CooperSurgical, Inc. D.B.A. Lone Star Medical Products is recalling Blunt Hurd Cannula Blunt Tip with Reducer simplifies open laparoscopy, distributed nationwide in the US. The recall was initiated on 13 Sep 2013 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-0147-2015
- FDA event ID
- 69446
- Recalling firm
- CooperSurgical, Inc. D.B.A. Lone Star Medical Products, Stafford, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Sep 2013
- FDA classified
- 29 Oct 2014
- Reported
- 5 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 13 Sep 2013 | Recall initiated by company | |
| 29 Oct 2014 | Classified by FDA | +411 days |
| 5 Nov 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CooperSurgical is recalling two lots of 900-863 because the wrong package insert (IFU) was placed into the shipper.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparoscopy.
Where it was distributed
Worldwide Distribution: US (nationwide) to North Carolina; and Internationally to Australia and Italy.
Questions about this recall
Why was it recalled?
CooperSurgical is recalling two lots of 900-863 because the wrong package insert (IFU) was placed into the shipper.
Which lots are affected?
Lots 149460 and 149911
Where was it sold?
Worldwide Distribution: US (nationwide) to North Carolina; and Internationally to Australia and Italy.
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 Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |