Arc Medical Inc: Medical Device Recall in 2015 - (Recall #: Z-1596-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.

Product Classification:

Class III

Date Initiated: February 19, 2015

Date Posted: May 20, 2015

Recall Number: Z-1596-2015

Event ID: 70662

Reason for Recall:

Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly.

Status: Terminated

Product Quantity: 1810 units

Code Information:

Product code: 6160, Batch number: 110208-50

Distribution Pattern:

Distributed in CA and NC.

Voluntary or Mandated:

Voluntary: Firm initiated