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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow WH02220 Epidural Catheterization Kit with FlexTip Plus(R) Catheter

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  Class 2 Device Recall Arrow WH02220 Epidural Catheterization Kit with FlexTip Plus(R) Catheter see related information
Date Initiated by Firm November 11, 2010
Date Posted February 01, 2011
Recall Status1 Terminated 3 on July 05, 2012
Recall Number Z-1012-2011
Recall Event ID 57259
510(K)Number K884552  
Product Classification Anesthesia conduction kit - Product Code CAZ
Product Arrow WH-02220 - Epidural Catheterization Kit with FlexTip Plus(R) Catheter
Intended use: Permits acccess to epidural space, Epidural Anesthesia Kit
Code Information Lot # RF0063961
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Road
Reading PA 19605
For Additional Information Contact Ms. Alice Harper
610-378-0131 Ext. 3548
Manufacturer Reason
for Recall		 Sterility may be compromised.
FDA Determined
Cause 2		 Employee error
Action The firm, Arrow International, issued an "URGENT MEDICAL DEVICE RECALL" letter dated November 11, 2010 to their consignees/customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to check their inventory for the affected products, cease use and distribution, quarantine all affected product immediately, return any affected product freight collect along with the completed form via mail to: Arrow International, Inc., 312 Commerce Place, Asheboro, NC 27203, Attn: Asheboro Quality Assurance Manager, and complete and return the FIELD SAFETY CORRECTIVE ACTION ACKNOWLEDGEMENT AND STOCK STATUS FORM via fax to: 800-343-2935. If you require additional information or clarification regarding this matter, please contact your sales representative, or Arrow's Customer Service Department at 866-396-2111.
Quantity in Commerce 2320
Distribution Nationwide Distribution: USA states including IL and LA.
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 = CAZ and Original Applicant = ARROW INTL., INC.
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