FDA recall Z-2957-2018

Product

FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL APPLICATOR TIPS***6 x Malleable Tip Trimmable Tip***Baxter***." The pouches inside the cartons are labeled in part, "Floseal SPECIAL APPLICATOR TIPS***Baxter***"."

Reason for recall

Baxter r recalled this device due to the use of an incorrect plastic formulation in the manufacture of the blue luer component of the FLOSEAL malleable tips.

Distribution

Nationwide distribution to AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. International distribution to Australia, Korea, Taiwan, Columbia.

Key facts

Status

Ongoing

Initiation date

2018-05-30

Report date

2018-09-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2957-2018