Date Initiated by Firm | April 04, 2003 |
Date Posted | May 15, 2003 |
Recall Status1 |
Terminated 3 on July 30, 2003 |
Recall Number | Z-0832-03 |
Recall Event ID |
26054 |
510(K)Number | K945499 |
Product Classification |
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
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Product | BD First PICC 3F 65 cm Single Lumen Procedure Kit. |
Code Information |
Reference No. 384134, Lot No. 2326770. |
Recalling Firm/ Manufacturer |
Becton Dickinson Infusion Therapy 9450 South State Street Sandy UT 84070
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For Additional Information Contact | Ms. Rachel LeBlanc 801-565-2649 |
Manufacturer Reason for Recall | A 4 Fr catheter was packaged in PICC convenience kits labeled as 3 Fr. |
FDA Determined Cause 2 | Other |
Action | All distributors and known hospitals were notified on 04/04/2003 by telephone, followed by a fax notification. |
Quantity in Commerce | 840 kits |
Distribution | Nationwide |
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 = LJS
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