Skip to content
Recall Observatory FDA recall evidence

Device product

EZ Breathe Medication Cup. For the delivery of liquid medications for respiratory usage.

Z-1373-2013

April 30, 2013

Class I

Product summary

Firm
Nephron Pharmaceuticals Corp.
Event
Event 65070
Status
Terminated
Classification
Class I
Quantity
750 Medications Cups
Official record key
device-enforcement:Z-1373-2013

Official wording

Reason: Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.

Code information: Lots #120902, Lot # 120903 and Lot # 120904

Distribution pattern: Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AZ, CA, CO, CT, FL, IL, IN, IO, GA, KS, KY, LA, MD, MN, MS, MO, NK, NV, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN , TX, VT, VA, WA, and WV, and the countries of Guatemala, Poland, Panama, and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.