| Class 3 Device Recall ProLong | |
Date Initiated by Firm | May 09, 2001 |
Date Posted | July 15, 2003 |
Recall Status1 |
Terminated 3 on July 15, 2003 |
Recall Number | Z-1003-03 |
Recall Event ID |
26498 |
510(K)Number | K001129 |
Product Classification |
Anesthesia Conduction Kit - Product Code CAZ
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Product | ProLong Continuous Nerve Block Set model nubers PL-50 and PL-100 |
Code Information |
All manufacturing codes were recalled. Model numbers: PL-50, PL-100 |
Recalling Firm/ Manufacturer |
Life-Tech International, Inc 4235 Greenbriar Dr Stafford TX 77477-3995
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Manufacturer Reason for Recall | Catheter does not fit through the needle resulting in delay of medical procedure |
FDA Determined Cause 2 | Other |
Action | The firm initiated the recall via letter to all consignees on May 9, 2001. |
Distribution | CA, MN, TX, FL, UT, |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = CAZ
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