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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter, RAPIDFILL Syringe

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  Class 2 Device Recall Baxter, RAPIDFILL Syringe see related information
Date Initiated by Firm December 21, 2015
Date Posted January 30, 2016
Recall Status1 Terminated 3 on August 18, 2016
Recall Number Z-0731-2016
Recall Event ID 72946
510(K)Number K980181  
Product Classification Syringe, piston - Product Code FMF
Product Baxter, RAPIDFILL Syringe Strip, 10 ml.
For use with RAPIDFILL Automated Syringe Filler (ASF)
Code Information All Lots
Recalling Firm/
Baxter Corporation Englewood
9540 Maroon Cir Unit 400
Englewood CO 80112-5731
For Additional Information Contact Center for One Baxter
Manufacturer Reason
for Recall
All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging claim for 12-month shelf life on released product.
FDA Determined
Cause 2
Packaging process control
Action An Urgent Product Recall notification was sent to consignees via USPS, first class mail on 12/21/15. Baxter Healthcare has asked customers to do the following: l. Locate and remove all affected product from your facility. The product code and lot number can be found on the individual product or shipping carton. 2. Contact Baxter Healthcare Center for Service to arrange for return, credit and alternative products. 3. Complete the attached customer reply form and return it to Baxter by either fax or scanned e-mail. 4. Communicate the contents of the letter to your staff if affected products are distributed to other facilities or departments. 5. Conduct a consumer-level recall for dealers, wholesalers, distributors, resellers, or Original Equipment Manufacturers that distributed affected product to other facilities.
Quantity in Commerce 4,695
Distribution Worldwide Distribution-US (nationwide) and the countries of Canada, Sweden, Germany, and the Netherlands.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FMF and Original Applicant = TERUMO MEDICAL CORP.