The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0119-2018·Announced 2017-11-29

Halyard Closed Suction System Saline Vials Recalled for Potential Leaking

Halyard Health is recalling specific lots of saline vials used in closed suction systems because they 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 is classified as FDA Class II. The hazard involves potential exposure to infectious agents due to leaking, which is a risk-of-harm scenario where injury has not yet been reported, fitting 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 involves 52,660 kits (2,633 cases) containing a total of 631,920 saline vials. The affected product codes and lots are: Product Code 22106 with Lots AB6011U20, AB6123U07, AB6123U01, AB3207U04, and AB6284U17; Product Code 221036 with Lot AB6263U11; and Product Code 22108147 with Lots AB6011U15, AB6067U17, and AB6256U13.

The recall was initiated because the saline vials 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 facilities in 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 product codes and lot numbers listed above and stop using any affected units.

The recalled product

Product
Halyard Closed Suction System for Adults, 14 F, DSE, 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 (8)

  • Product Code 22106 with Lots AB6011U20
  • AB6123U07 AB6123U01
  • AB3207U04
  • AB6284U17
  • Product Code 221036 with Lot AB6263U11
  • Product Code 22108147 with Lots AB6011U15
  • AB6067U17
  • AB6256U13

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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