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U.S. Department of Health and Human Services

Class 2 Device Recall Continuous Nerve Block Needle

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 Class 2 Device Recall Continuous Nerve Block Needlesee related information
Date Initiated by FirmFebruary 17, 2005
Date PostedJune 01, 2005
Recall Status1 Terminated 3 on May 05, 2006
Recall NumberZ-0852-05
Recall Event ID 31215
510(K)NumberK021567 
Product Classification Anesthesia Conduction Kit - Product Code CAZ
ProductArrow Continuous Nerve Block Needle, Latex-Free* Rx only*Sterile*Arrow International Inc., 2400 Bernville, Road, Reading, PA 19605 USA
Code Information Product #AB-17040-N, AB-17080-N, AB-17110-N, AB-17140-N, AB-18040-N, AB-18080-N, AB-18110-N, AB-18140-N, AB-19604-K, AB-19604-S, AB-19608-K, AB-19608-S, AB-20604-K, AB-20604-S, AB-20608-K, AB-20608-S
FEI Number 3015859709
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information ContactMr. Scott Carlisle
336-498-4153 Ext. 209
Manufacturer Reason
for Recall		Possible difficulty in passing the catheter through the needle due to a reduced ID of the needle caused by over crimping of the needle during the manufacturing process.
FDA Determined
Cause 2		Other
ActionConsignees were notifed by letter on/about 02/17/2005
DistributionNationwide, Africa , France, Holland, Rotterdam
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CAZ
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