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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow International StimuCath(R) Continuous Nerve Block Kit, ASK19608SFH

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  Class 2 Device Recall Arrow International StimuCath(R) Continuous Nerve Block Kit, ASK19608SFH see related information
Date Initiated by Firm June 20, 2011
Date Posted November 30, 2011
Recall Status1 Terminated 3 on October 01, 2012
Recall Number Z-0309-2012
Recall Event ID 60314
510(K)Number K021567  
Product Classification Anesthesia conduction kit - Product Code CAZ
Product Arrow International StimuCath(R) Continuous Nerve Block Kit, ASK-19608-SFH, Lot # MF0127039

Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia of analgesia techniques for periods not exceeding 72 hours
Code Information Lot number MF0127039
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Road
Reading PA 19605
For Additional Information Contact Tracy Larish
610-378-0131
Manufacturer Reason
for Recall		 Some of the outer trays used in the packaging of the ASK-19608-SFH Continuous Nerve Block Kits, lot # MF0127039 were found to have an insufficient seal. Therefore, the packaging may have been compromised, and sterility of the product cannot be guaranteed.
FDA Determined
Cause 2		 Packaging
Action The firm, Arrow International, sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 20, 2011, to its customer. The letter included a stock response form to be completed and returned to the firm. The letter also described the product, problem and action to be taken. The customer was instructed to check their stock for the products included in the scope of the recall; cease use and distribution; quarantine all affected product immediately; complete and return the enclosed Recall Acknowledgement & Stock Status Form to their sales representative, and return any affected product freight collect to: Arrow International, Inc., 312 Commerce Place, Asheboro, NC 27203, attn: Asheboro Quality Assurance Manager. Arrow International can provide replacement with a similar product or credit their account. If you have questions or concerns, please call this toll free number 800-233-3187.
Quantity in Commerce 17 kits
Distribution Nationwide distribution: CT
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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