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U.S. Department of Health and Human Services

Class 2 Device Recall Triton Administration Sets

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  Class 2 Device Recall Triton Administration Sets see related information
Date Initiated by Firm June 14, 2016
Create Date July 18, 2016
Recall Status1 Terminated 3 on December 01, 2016
Recall Number Z-2231-2016
Recall Event ID 74437
510(K)Number K073444  
Product Classification Set, administration, intravascular - Product Code FPA
Product T100-000WF, IV Set with Upper Y-Site, Lower Y-Site, Back Check Valve, and Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case.

Product Usage:
Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
Code Information Product Number: 020-300644. Lot Number: 1406019, 1406020, 1407020, 1407021, 1407022, 1407120, 1407121, 1408133, 1501111D, 1506067D, 1507020D, 1507060D, 1508073D
Recalling Firm/
Manufacturer		 WalkMed Infusion, LLC
6555 S Kenton St Ste 304
Englewood CO 80111-6838
For Additional Information Contact Sally Leonard
303-420-9569
Manufacturer Reason
for Recall		 WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Terumo sent a notification letter dated June 8, 2016 to customers. The letter identified the affected product, problem and action to be taken. Customers were instructed to 1. Review this notice and ensure that all users receive notice of this issue. 2. Return the attached Customer Response Form acknowledging receipt of this notice. 3. Source a replacement for the Interchlor sanitizer. See information above or call Terumo CVS Technical Support for assistance. 4. Terumo CVS will provide users with updated user instructions regarding the 10% Sodium Hypochlorite sanitization solution. Instructions will be provided under separate cover, when available. For questions contact your Terumo representative or contact Terumo CVS Technical Support at 800.441.3220, extension 6932.
Quantity in Commerce 2198 cases
Distribution US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.
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 = FPA and Original Applicant = TRITON MEDICAL, LLC
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