| Class 2 Device Recall Symbiq Infuser | |
Date Initiated by Firm | February 22, 2010 |
Date Posted | September 09, 2010 |
Recall Status1 |
Terminated 3 on April 01, 2011 |
Recall Number | Z-2391-2010 |
Recall Event ID |
56464 |
510(K)Number | K041550 |
Product Classification |
Pump, infusion - Product Code FRN
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Product | Hospira brand Symbiq Two-Channel Infuser,
LIST No. 16027 Symbiq Two-Channel Infuser,
List Number Configurations:
16027-04-01/03/04, 51/52, 53/54, 79/80,81/82,83/84,87/88 and 89/90 16026-27-89/90,
16027-27-89/90, 16027-13-25/26,53/54,
Distributed by: Hospira, Inc. Morgan Hill, CA |
Code Information |
All units of these List Numbers. |
Recalling Firm/ Manufacturer |
Hospira Inc 755 Jarvis Dr Morgan Hill CA 95037-2810
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For Additional Information Contact | 408-782-3200 |
Manufacturer Reason for Recall | The clamp may not secure to the IV pole and the pump may slip or fall off. The pump may fall on a person or pull the tubing out of the IV container. |
FDA Determined Cause 2 | Device Design |
Action | Hospira issued an "Urgent: Device Field Correction" Letter dated February 22, 2010 to all consignees, identifying the reason for the recall and affected product. Customers were informed that they will be contacted by a Hospira representative to replace the affected pole clamps. Consignees can contact Hospira Technical Support Operations at 1-800-241-4002. |
Distribution | Worldwide Distribution: USA (all states and Puerto Rico) and the countries of Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Singapore. and the UAE. |
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 = FRN
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