Halyard Turbo-Cleaning Closed Suction System Recalled for Leaking Saline Vials
Halyard Health is recalling Turbo-Cleaning Closed Suction Systems because 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 the source text does not report any confirmed illnesses or injuries, placing it in the 'High' category per the rubric.
Plain-English summary
Halyard Health, Inc. is recalling the Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, Wet Pak. The recall involves 52,660 kits (2,633 cases) containing 631,920 saline vials. The affected product codes are 2276, and the specific lots are AB6018U03, AB6137U12, and AB6305U17.
The recall was initiated after Smiths Medical notified the FDA that the 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 AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, PA, PR, RI, SC, SD, TN, TX, VA, WA, and WV. Users should check their inventory for the affected lot numbers and stop using the product if it matches the recall description.
The recalled product
- Product
- Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 saline 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 (4)
- Product Code 2276
- Lots AB6018U03
- AB6137U12
- AB6305U17.
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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