Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four… — Class II medical device recall Z-1573-2015
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-1573-2015 |
|---|---|
| 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 | 10097012, 10105012, 10130012, 10162012, 10172012, 10195012, 10205012, 10238012, 10251012, 10272012, 10281012, 10298012, 10312012, 10322012, 10337012, 10340012, 11003012, 11013012, 11048012, 11055012, 11087012, 11095012, 11105012, 11115012, 11130012, 11139012, 11146012, 11147012, 11151012, 11160012, 11178012, 11189012, 11206012, 11229012, 11269012, 11313012, 11337012, 12016012, 12040012, 12041012 and 34 more |
| Model numbers | 0225-028-852 |
Product
Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main components: the suction reservoir, the PVC tubing, the slide clamp and the female connector. The rigid polycarbonate female connector is used to connect the ambulating bulb to the CBCII evacuator tube in order to collect wound drainage.
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-1573-2015. 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.