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***"."
- Company
- Baxter Healthcare Corporation
- Recall Initiated
- May 30, 2018
- Recall Number
- Z-2957-2018
- Quantity
- 46,908 pouches
- Firm Location
- Deerfield, IL
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.
Lot / Code Info
Product Code: 1502186; Box Lot Numbers: HA170718, HA170818, and HA170917; Pouch Lot Numbers: GR338160 and GR338384
Root Cause
Mixed-up of materials/components
Action Taken
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.