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***"."
FDA Recall Z-2957-2018 · Posted None
Advertisement
Recalling FirmBaxter Healthcare Corporation
Recall StatusOpen, Classified
Product CodePMX
Date Initiated2018-05-30
Product Quantity46,908 pouches
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.
Firm Action
Baxter Healthcare notified customers of the recall on 05/30/2018 via Urgent Product Recall letter to the Directors of Pharmacy. Instructions included to locate and remove all affected product from inventory, contact Baxter Healthcare Center for Service to arrange for return of affected devices, complete and return the enclosed Baxter customer reply form, and notify customers if further distributed.
Adverse reactions to the product can be reported to FDA MedWatch Adverse Event Reporting program and/or Baxter Corporate Product Surveillance at 800-437-5176 between the hours of 8;00 AM and 5:00 PM Central Time, Monday through Friday.
Root Cause
Mixed-up of materials/components
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement