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U.S. Department of Health and Human Services

Class 2 Device Recall FLOSEAL Special Applicator Tips

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  Class 2 Device Recall FLOSEAL Special Applicator Tips see related information
Date Initiated by Firm May 30, 2018
Create Date August 30, 2018
Recall Status1 Open3, Classified
Recall Number Z-2957-2018
Recall Event ID 80757
PMA Number P990009 
Product Classification Absorbable collagen hemostatic agent with thrombin - Product Code PMX
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***"."
Code Information Product Code: 1502186; Box Lot Numbers: HA170718, HA170818, and HA170917; Pouch Lot Numbers: GR338160 and GR338384
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact
800-422-9837
Manufacturer 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.
FDA Determined
Cause 2		 Mixed-up of materials/components
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.
Quantity in Commerce 46,908 pouches
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = PMX and Original Applicant = BAXTER HEALTHCARE CORP.
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