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U.S. Department of Health and Human Services

Class 3 Device Recall Epidural Needle

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  Class 3 Device Recall Epidural Needle see related information
Date Initiated by Firm June 07, 2004
Date Posted July 31, 2004
Recall Status1 Terminated 3 on September 21, 2004
Recall Number Z-1300-04
Recall Event ID 29463
Product Classification Anesthesia Conduction Kit - Product Code CAZ
Product ARROW EPIDURAL CATHETERIZATION KIT. Product No. MC-05001.
Code Information Lot No. RF4044686, expiration date 2006-09
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact Ms. Jody Cadd
610-378-0131 Ext. 3318
Manufacturer Reason
for Recall		 The recall is due to a confirmed packaging error of the wrong epidural needle (longer than stated).
FDA Determined
Cause 2		 Other
Action The recalling firm sent a recall letter to its direct accounts to notify of the recall action and that the wrong epidural needle was packaged in the kits. The letter instructed the accounts to returned the kits to the recalling firm''s Asheboro, NC facility for rework and resterilization.
Quantity in Commerce 270 units
Distribution The recalled kits with the wrong epidural needle was distributed to the following direct accounts, to the following states in TN and TX
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.
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