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U.S. Department of Health and Human Services

Class 2 Device Recall Cadence Science

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  Class 2 Device Recall Cadence Science see related information
Date Initiated by Firm May 10, 2019
Create Date November 13, 2019
Recall Status1 Terminated 3 on June 05, 2020
Recall Number Z-0365-2020
Recall Event ID 83867
Product Classification Syringe, piston - Product Code FMF
Product Cadence Science Pressure Control Glass Syringe, Part Nos. 5338 (GTIN #816329023381); 5339 (GTIN #816329023398); 5340 (GTIN #816329023404); 5341 (GTIN #816329023411); 5342 (GTIN #816329023428); 5343 (GTIN #816329023435) - Product Usage: General Hospital Use
Code Information Catalog Number 5338: W037053/1, W037199/1, W037450/1, W040276/1, W042297/1, W040804/1, W045558/1, W049244/1;  Catalog Number 5339: W020584/1;  Catalog Number 5340: W033034/1, W046909/1, W047793/1, W048648/1, W049141/1, W049853/1, W050262/1, W051186/1;  Catalog Number 5341: W029677/1, W037708/1, W040478/1, W043484/1, W049850/1, W051158/1;  Catalog Number 5342: W026119/1, W034575/1, W044966/1, W045378/1, W045956/1, W046139/1, W048329/1, W049083/1, W049786/1, W051013/1, W052622/1;  Catalog Number 5343: W030380/1, W039777/1, W040479/1
Recalling Firm/
Manufacturer		 Cadence Science, Inc.
2080 Plainfield Pike
Cranston RI 02921-2012
For Additional Information Contact Charles Funkhouser
401-9421031 Ext. 4226
Manufacturer Reason
for Recall		 The glass syringe used with Pressure Control Syringes may potentially break during use.
FDA Determined
Cause 2		 Under Investigation by firm
Action On May 10, 2019, the firm distributed Advisory Notice letters to affected customers. Customers were advised of the potential issue involving breakage of the glass syringe used with Pressure Control Syringes. The firm recommended that the customer inspect the product for this issue prior to use in accordance with the Instructions For Use (IFU) which were provided with the product. The firm provided an additional IFU with the notification. Upon successful inspection, the firm recommended that customers continue to use the product in accordance with the IFU and continue to follow all OSHA recommendations for the safe handling of chemicals to include PPE. Customers may contact Chuck Funkhouser at 401-942-1031, ext. 4226 or Charles.Funkhouser@cadenceinc.com, or Jeff Crist at 540-245-1022 or Jeff@cadenceinc.com with any questions.
Quantity in Commerce 237
Distribution US Nationwide distribution in the states of AL, AR, CA, FL, GA, IA, ID, IL, MO, NH, NJ, NY, OH, PA, SC, TX, VA, and WI.
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.
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