3/16 in — Class II medical device recall Z-1568-2015
Terminated recall by Stryker Instruments Div. of Stryker Corporation, reported 2015-05-13, distributed nationwide. Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential steril
| Recall number | Z-1568-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2015-03-26 |
| Classified | 2015-05-01 |
| Reported by FDA | 2015-05-13 |
| Terminated | 2015-12-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CH, ES, GB, GR, JP, NL, RO, ZA |
| Reason classes | sterility |
| Lot numbers | 10074012, 10104012, 10147012, 10153012, 10231012, 10263012, 10279012, 10309012, 10337012, 11012012, 11055012, 11110012, 11122012, 11185012, 11216012, 11252012, 11348012, 12053012, 12082012, 12116012, 12172012, 12237012, 12318012, 12331012, 13081012, 13126012, 13163012, 13211012, 14044012, 14147012, 14153012 |
| Model numbers | 0215-031-000 |
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 for recall
Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1568-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.