The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0120-2018·Announced 2017-11-29

Halyard Closed Suction System Recalled for Potential Saline Vial Leaks

Halyard Health is recalling specific lots of Closed Suction Systems because the 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 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 22169 and Lots AB6123U08 and AB6123U11.

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 FDA has classified this as a Class II recall.

The affected products were distributed domestically to 38 states and Puerto Rico. Consumers and healthcare facilities should check their inventory for the specific product code and lot numbers listed above. If the products are found, they should be removed from use and returned to the distributor or manufacturer according to recall instructions.

The recalled product

Product
Halyard Closed Suction System for Adults, 14 F, Elbow, Directional Tip, Wet Pak. 12 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 (3)

  • Product Code 22169
  • Lots AB6123U08
  • AB6123U11

Distribution

Distributed in 38 states:

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 →

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