KimVent Microcuff Subglottic Suctioning — Class I medical device recall Z-0867-2015
Terminated recall by Halyard Health, reported 2014-12-31, distributed nationwide. The cuff inflation line may detach from the endotracheal tube during use.
| Recall number | Z-0867-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Halyard Health, Roswell, GA, United States |
| Recall initiated | 2014-11-17 |
| Classified | 2014-12-24 |
| Reported by FDA | 2014-12-31 |
| Terminated | 2015-08-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CA, CH, DE, FR, GB, HK, IE, IT, NL, NZ, PT, SE |
| Reason classes | device malfunction |
| Lot numbers | AA3213, AA3213V03, AA3227, AA3227V01, AA3239, AA3239V01, AA3245, AA3245V02, AA3249, AA3249V01, AA3249V03, AA3253V02, AA3269V01, AA3274, AA3274V01, AA3274V04, AA4038, AA4038V03, AA4038V04, AA4038V06, AA4062, AA4062V01, AA4062V03, AA4062V04, AA4083, AA4083V02, AA4097, AA4097V02, AA4097V04, AA4104V01, AA4104V02, AA4111, AA4111V01, AA4111V02, AA4113V01, AA4125V03, AA4134V01, AA4146V01, AA4146V04, AA4155V03 and 5 more |
Product
KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
Reason for recall
The cuff inflation line may detach from the endotracheal tube during use.
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-0867-2015. 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.