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Class 2 Device Recall Cadence Science |
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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
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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
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For Additional Information Contact |
Charles Funkhouser 401-9421031 Ext. 4226
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Manufacturer Reason for Recall |
The glass syringe used with Pressure Control Syringes may potentially break during use.
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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
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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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