FDA Device recall Z-1569-2015
1/4 in
- FDA Device
- Class II
- terminated
- Published 2015-05-13
On 2015-05-13 the FDA classified a Class II recall of 1/4 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-1569-2015 |
| 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
1/4 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: 0215-032-000 and lot numbers: 10098012 10279012 11017012 11131012 12033012 12275012 13128012 140630…Part Number: 0215-032-000 and lot numbers: 10098012 10279012 11017012 11131012 12033012 12275012 13128012 14063012 10165012 10343012 11122012 11159012 12137012 13025012 13343012 14105012 |
|---|
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-1569-2015%22
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