The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0117-2018·Announced 2017-11-29

Halyard Closed Suction System Recalled for Potential Saline Vial Leaking

Halyard Health is recalling specific lots of Closed Suction Systems because 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 High severity score.

Plain-English summary

Halyard Health, Inc. is recalling specific lots of the Halyard Closed Suction System for Adults with BALLARD Technology WET PAK. The recall involves 52,660 kits, which contain a total of 631,920 saline vials. The affected products are identified by Product Code 2216 with Lot AB6032U03, Product Code 22056 with Lot AB6032U12, and Product Code 220569 with Lot AB6207U11.

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 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.

Healthcare facilities and consumers should check their inventory for the specific product codes and lot numbers listed above. If the affected products are found, they should be removed from use and returned to the distributor or manufacturer in accordance with the recall instructions.

The recalled product

Product
Halyard Closed Suction System for Adults with BALLARD Technology WET PAK. 12 saline 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 2216 with Lot AB6032U03
  • Product Code 22056 with Lot AB6032U12
  • Product Code 220569 with Lot AB6207U11

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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