Halyard Health Recalls NOVAPLUS Endotracheal Suction Kits Due to Leaking Vials
Halyard Health is recalling NOVAPLUS Endotracheal WET PAK 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 the source text does not report any confirmed illnesses or injuries, fitting the criteria for a score of 3.
Plain-English summary
Halyard Health, Inc. is recalling NOVAPLUS Endotracheal WET PAK Closed Suction Systems for Adults with BALLARD Technology, Double Swivel Elbow, 14 F. The recall involves 52,660 kits (2,633 cases) containing 631,920 saline vials. The specific product code is 2V22108147 with Lot AB6018U07.
The recall was initiated after Smiths Medical notified the FDA that 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 affected products were 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. Healthcare facilities and consumers should stop using the affected lots and contact Halyard Health for further instructions.
The recalled product
- Product
- NOVAPLUS* Endotracheal WET PAK* Closed Suction System for Adults with BALLARD* Technology, Double Swivel Elbow, 14 F. 6 vials per kit, 20 kits per case.
- Manufacturer
- Halyard Health, Inc
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 2V22108147 with Lot AB6018U07
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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