Z-1373-2013 Class I Terminated
FDA device recall Z-1373-2013 was initiated by Nephron Pharmaceuticals Corp. on April 30, 2013 and is designated Class I. Reason for recall: Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard. The recall status is terminated (terminated June 28, 2016). Affected quantity: 750 Medications Cups.
Recall Details
- Product Type
- Devices
- Report Date
- June 5, 2013
- Initiation Date
- April 30, 2013
- Termination Date
- June 28, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 750 Medications Cups
Product Description
EZ Breathe Medication Cup. For the delivery of liquid medications for respiratory usage.
Reason for Recall
Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.
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.
Code Information
Lots #120902, Lot # 120903 and Lot # 120904