Halyard Turbo-Cleaning Closed Suction System Recalled for Potential Saline Vial Leaking
Halyard Health is recalling Turbo-Cleaning Closed Suction Systems because 15ml saline vials may leak, potentially exposing contents to infectious agents.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of exposure to infectious agents, which is a high-risk hazard, but no illnesses or injuries have been reported in the source text.
Plain-English summary
Halyard Health, Inc. is recalling the Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI, Wet Pak. The recall involves 52,660 kits (2,633 cases) containing 631,920 saline vials. The affected product is identified by Product Code 22714186 and Lot AB6088U01.
The recall was initiated because lots of 15ml Saline Vials may be susceptible to leaking. This defect could potentially result in the exposure of the saline contents to infectious agents. The product was distributed domestically to 38 states and Puerto Rico.
Consumers and healthcare facilities should stop using the affected product and contact Halyard Health for further instructions or a refund.
The recalled product
- Product
- Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI, Wet Pak. 12 vials per kit, 20 kits per case.
- Manufacturer
- Halyard Health, Inc
- Category
- Medical Device — Suction Systems
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Product Code 22714186 with Lot AB6088U01
Distribution
Part of a larger recall action
This product is one of 9 recalled by Halyard Health, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
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