AsthmaNefrin Starter Kit contains ten (10) AsthmaNefrin vials and one (1) EZ Breathe Atomizer. For the delivery of liqui

FDA device recall Z-1372-2013 · posted 2013-05-29 · Terminated

Recall details

Recalling firm

Nephron Pharmaceuticals Corp.

Reason for recall

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

Action taken

The firm, Nephron Pharmaceuticals Corporation, notified its consignees on April 30, 2013, and May 3, 2013, of the problem via a recall notice and a Press Release, respectively. The firm directed consignees to discontinue use of any EZ Breathe atomizer units contained in the Asthmanefrin Starter Kits with the affected lot numbers and also those that were sold individually. Customers were directed to return all affected product.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

CCQ

Quantity affected

241,538 kits

Distribution

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, T

Date initiated

2013-04-30

Date posted

2013-05-29

Date terminated

2016-06-28

Location

Orlando, FL