FDA recall Z-1308-2018

Product

Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is packaged in an individual pouch. Urinary catheter.

Reason for recall

Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.

Distribution

US Nationwide in the states of AK, AL, AR, AZ, CA, FL, GA, HI, IA, ID, KS, KY, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, including Puerto Rico

Key facts

Status

Terminated

Initiation date

2017-09-14

Report date

2018-04-11

Termination date

2019-11-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Covington, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1308-2018