FDA Device recall Z-1562-2015
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-1562-2015 |
| 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. Trocar with Single Drain 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: 0215-015-000 and lot numbers: 10090012 10272012 11110012 11264012 12044012 12249012 13144012 140350…Part Number: 0215-015-000 and lot numbers: 10090012 10272012 11110012 11264012 12044012 12249012 13144012 14035012 10104012 10292012 11126012 11269012 12051012 12264012 13176012 14057012 10123012 10320012 11143012 11287012 12081012 12297012 13217012 14088012 10141012 10334012 11146012 11298012 12116012 12339012 13247012 14167012 10158012 10344012 11146022 11318012 12139012 12353012 13266012 14168012 10187012 11005012 11159012 11337012 12152012 13003012 13276012 14213012 10208012 11041012 11194012 11346012 12159012 13008012 13294012 14253012 10228012 11048012 11213012 12011012 12179012 13105012 13312012 14265012 10236012 11075012 11244012 12023012 12228012 13119012 13338012 |
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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-1562-2015%22
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