| Class 1 Device Recall Symbiq Infuser | |
Date Initiated by Firm | March 26, 2010 |
Date Posted | September 08, 2010 |
Recall Status1 |
Terminated 3 on March 30, 2012 |
Recall Number | Z-2381-2010 |
Recall Event ID |
56523 |
510(K)Number | K041550 |
Product Classification |
infuser - Product Code FRN
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Product | Hospira Inc. Symbiq One- and Two- Channel Infuser, List Numbers 16026 and 16027 respectively. |
Code Information |
List number configurations: 16026-04-01/03/04, 51/52, 53/54, 79/80, 81/82, 83/84, 87/88, 89/90; 16027-04-01/03/04, 51/52, 53/54, 79/80, 81/82, 83/84, 87/88, 89/90; 16026-27-89/90, 16026-13-25/26, 53/54; 16027-27-89/90; 16027-13-25/26, 53/54. |
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 | If the administrator set is removed prior to the cassette carriage fully opening without closing the slide/roller clamp, unrestricted flow and delivery may result. |
FDA Determined Cause 2 | Device Design |
Action | Hospitra Urgent Device Correction Notification mailed on 03/26/2010 via federal express. Tracking done by delivery tracking. Distribution of product continues and has not stopped. Additional notification was issued in 09/2010. A software correction is planned. |
Quantity in Commerce | 28485 units |
Distribution | Worldwide distribution: USA, Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Puerto Rico, 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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