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U.S. Department of Health and Human Services

Class 2 Device Recall ARROW HANDSOFF Infusion Port Thermodilution Catheter

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  Class 2 Device Recall ARROW HANDSOFF Infusion Port Thermodilution Catheter see related information
Date Initiated by Firm September 02, 2016
Create Date November 02, 2016
Recall Status1 Terminated 3 on February 20, 2020
Recall Number Z-0331-2017
Recall Event ID 75372
510(K)Number K895268  
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
Product HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contamination shield (Arrow Cath-Gard) with integral flushing/balloon test chamber, enabling the practitioner to prepare, test, and insert the catheter without exposing it to external contamination.
Code Information Lot # 16F15C0114, 16F15D0003, 16F15A0072, 16F15F0031, 16F15F0090, 16F15H0037, 16F16B0001, 16F16B0014, 16F16C0056, 16F16C0079, 16F16C0109, 16F16E0004, 16F16E0030
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact
610-378-0131
Manufacturer Reason
for Recall		 Labeling inconsistency
FDA Determined
Cause 2		 Labeling mix-ups
Action Arrow sent an Urgent Medical Device Recall Notification letter dated September 20, 2016, to all affected customers via FedEx 2-day air. The letter identified the problem and provided instructions to immediately discontinue use and quarantine any products with the associated lot numbers indicated in the letter. If product was found, customers were asked to complete the Recall Acknowledgement Form and a Customer Service Rep will issue a Return Goods Authorization (RGA) Number for the product's return. Disposition of recalled product will be scrapped. For further questions, please call (610) 378-0131
Quantity in Commerce 330 units in US and 1,031 units OUS
Distribution Nationwide distribution
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 = DQO and Original Applicant = ARROW INTL., INC.
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