The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0124-2018·Announced 2017-11-29

Halyard Closed Suction System Saline Vials Recalled for Leaking Risk

Halyard Health is recalling specific lots of saline vials used in closed suction systems because they may leak, potentially exposing the 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 medical device with a defect that could lead to exposure to infectious agents, representing a risk of harm where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

Halyard Health, Inc. is recalling specific lots of 15ml Saline Vials used in the Halyard Closed Suction System for Adults. The recall was initiated after Smiths Medical notified the FDA that these vials may be susceptible to leaking. This defect could potentially result in the exposure of the saline contents to infectious agents.

The affected product is the Halyard Closed Suction System for Adults, 14 F, T-Piece, MDI, Wet Pak. The recall covers 52,660 kits (2,633 cases) containing 631,920 saline vials. The specific product code is 220123568, and the affected lot numbers are AB6151U08 and AB6207U13.

These products were distributed domestically to numerous states and territories, including Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, and West Virginia. Users should check their inventory for the specific lot numbers listed and stop using the affected vials if found.

The recalled product

Product
Halyard Closed Suction System for Adults, 14 F, T-Piece, MDI, 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 (2)

  • Product Code 220123568 with Lot AB6151U08
  • AB6207U13

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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