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U.S. Department of Health and Human Services

Class 2 Device Recall Freedom 60 Precision Flow Rate Tubing Sets

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  Class 2 Device Recall Freedom 60 Precision Flow Rate Tubing Sets see related information
Date Initiated by Firm March 10, 2016
Date Posted January 05, 2018
Recall Status1 Terminated 3 on February 26, 2018
Recall Number Z-0317-2018
Recall Event ID 76569
510(K)Number K933652  
Product Classification Pump, infusion - Product Code FRN
Product Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F600, F45, F1200 F180.
Code Information Lot Numbers: 1.053/16, 1.052/16, 1.051/16, 1.050/16, 1.049/16, 1.048/16, 1.047/16, 1.042/16, 1.041/16, 1.040/16, 1.039/16, 1.038/16, 1.037/16, 1.036/16, 1.033/16, & 1.030/16  Expiration: 2021-02
Recalling Firm/
Manufacturer		 Repro-Med Systems, Inc.
24 Carpenter Rd
Chester NY 10918-1057
Manufacturer Reason
for Recall		 On 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing, Lot number 1.042/16 the firm found 701 out of 3,195 were rejected due to visual defect, gap in the supplier s manufacturing seal for Part number #317036 5 X 6.5 ST Bag Combo. the firm decided to recall Precision Flow Rate Tubing and RMS HIgH-Flo Subcutaneous Safety Needles Sets due to the sterile barrier packaging being found to have gaps during post-sterilization inspection of one lot of flow tubing, in which 701 out of 3,195 units were rejected for not passing inspection. The firm determined that the issue was large than just the one lot and recalled the product via March 10, 2016 Voluntary Medical Device Corrections and Removal Notification to customers. The recall was conducted without FDA notification.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On March 10, 2016 RMS Medical Products distributed Urgent Voluntary Medical Device Corrections and Removal notices to their customers. On March 12, 2016 & on March 18, 2016, RMS Medical Products distributed a 2nd Urgent Voluntary Medical Device Corrections and Removal notices to their customers advising them that affected products list was reduced after a comprehensive risk assessment was performed. Customers are advised to check stock, quarantine, cease distribution and remove product from use. If customers further distributed product, they are also encouraged to inform the affected parties. Customers are encouraged to complete and return the acknowledgement form via fax to: 845-469-5518.
Distribution Nationwide in US
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 = FRN and Original Applicant = REPRO-MED SYSTEMS, INC.
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