FDA Device recall Z-1568-2015
3/16 in
- FDA Device
- Class II
- terminated
- Published 2015-05-13
On 2015-05-13 the FDA classified a Class II recall of 3/16 in by Stryker Instruments Div, citing stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1568-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-26 |
| Published | 2015-05-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Instruments Div |
| Distribution | US |
Product
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.
Reason
Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
Identifiers
| code_info | Part Number: 0215-031-000 and lot numbers: 10074012 10231012 10337012 11122012 11348012 12172012 13081012 140440…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1568-2015%22
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