—#166431

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***"."

FDA product code: PMX — Absorbable Collagen Hemostatic Agent With Thrombin
Device class: Class 3
Medical specialty: General, Plastic Surgery
PMA numbers: P990009
Affected lot / code info: Product Code: 1502186; Box Lot Numbers: HA170718, HA170818, and HA170917; Pouch Lot Numbers: GR338160 and GR338384

Why it was recalled

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.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

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.

Timeline

Recall initiated: 2018-05-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #166431. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.