CLASS II Device recall · Reported 13 May 2015 · FDA Enforcement Report
Round Drain with Trocar Curved Trocar recalled
Stryker Instruments Div. of Stryker is recalling Round Drain with Trocar Curved Trocar with Wound Drain/Double Trocar with Wound Drain, distributed nationwide in the US. The recall was initiated on 26 Mar 2015 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-1568-2015
- FDA event ID
- 70841
- Recalling firm
- Stryker Instruments Div. of Stryker, Portage, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Mar 2015
- FDA classified
- 1 May 2015
- Reported
- 13 May 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 26 Mar 2015 | Recall initiated by company | |
| 1 May 2015 | Classified by FDA | +36 days |
| 13 May 2015 | 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
Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
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
3/16 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.
Where it was distributed
Worldwide Distribution. US nationwide, Australia, Great Britain, The Netherlands, Spain, Romania, Greece, Switzerland, South Africa, and Japan.
Questions about this recall
Why was it recalled?
Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
Which lots are affected?
Part Number: 0215-031-000 and lot numbers: 10074012 10231012 10337012 11122012 11348012 12172012 13081012 14044012 10104012 10263012 11012012 11185012 12053012 12237012 13126012 14147012 10147012 10279012 11055012 11216012 12082012 12318012 13163012 14153012 10153012 10309012 11110012 11252012 12116012 12331012 13211012
Where was it sold?
Worldwide Distribution. US nationwide, Australia, Great Britain, The Netherlands, Spain, Romania, Greece, Switzerland, South Africa, and Japan.
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
11 other products · FDA event 70841This product is part of a recall event; the main page for the event is Double Trocar with Wound Drain Curved Trocar recalled.
More recalls from Stryker Instruments Div. of Stryker
All 161| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Triton Sponge System recalled by Stryker Instruments Div. of | Stryker Instruments Div. of Stryker | Device Malfunction | Nationwide |
| Device | CLASS II | Triton Canister System (finished part numbers FG recalled | Stryker Instruments Div. of Stryker | Device Malfunction | Nationwide |
| Device | CLASS II | SurgiCount+ System Application recalled by Stryker Instruments Div. of | Stryker Instruments Div. of Stryker | Device Malfunction | KS, ME |
| Device | CLASS II | Stryker Zyphr Disposable Cranial Perforator recalled | Stryker Instruments Div. of Stryker | Foreign Material | Nationwide |
| Device | CLASS II | Neptune E-sep Blade Electrode recalled by Stryker Instruments Div. of | Stryker Instruments Div. of Stryker | Other | MI |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |