Halyard Closed Suction System Recalled Due to Saline Vial Leaking Risk
Halyard Health is recalling specific lots of 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. The source text does not report any illnesses or injuries, placing this in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Halyard Health, Inc. is recalling specific lots of Halyard Closed Suction Systems for Adults. The recall involves 52,660 kits (2,633 cases) containing 631,920 saline vials. The affected products are identified by Product Code 22012356 with Lot AB6032U10 and Product Code 2208A055 with Lot AB6291U17.
The recall was initiated because the 15ml saline vials included in these kits 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 37 states and Puerto Rico. Consumers and healthcare facilities should check their inventory for the specific product codes and lot numbers listed above. If these products are found, they should be removed from use and returned to the supplier or manufacturer for credit.
The recalled product
- Product
- Halyard Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 or 6 vials per kit, 20 kits per case.
- Manufacturer
- Halyard Health, Inc
- Category
- Medical Device — Suction Systems
- Hazard
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 (2)
- Product Code 22012356 with Lot AB6032U10
- Product Code 2208A055 with Lot AB6291U17
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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