| Class 2 Device Recall LifeShield Symbiq Pump Set | |
Date Initiated by Firm | November 24, 2009 |
Date Posted | March 09, 2010 |
Recall Status1 |
Terminated 3 on January 29, 2012 |
Recall Number | Z-1060-2010 |
Recall Event ID |
54080 |
510(K)Number | K041550 |
Product Classification |
Set, administration, intravascular - Product Code FPA
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Product | Primary Symbiq Set, Latex-Free piggyback with backcheck valve, 3 prepierced Y-sites, 106 Inch, non-DEHP, 15 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 160960428, list number 16096-28. |
Code Information |
Lots numbers: 722045H, 820285H, and 840215H. |
Recalling Firm/ Manufacturer |
Hospira Inc. 375 N Field Dr Lake Forest IL 60045-2513
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For Additional Information Contact | Ms. Ileana Quinones 224-212-4892 |
Manufacturer Reason for Recall | Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets. |
FDA Determined Cause 2 | Process control |
Action | Hospira, Inc. issued an "Important Administration Set Information" letter dated November 24, 2009 to their direct accounts, informing them of the affected product. Consignees were instructed to return the defective product to the firm.
For further information, contact Hospira Medical Communications at 1-800-615-0187. |
Quantity in Commerce | 93,936 sets |
Distribution | Worldwide Distribution -- United States, Australia, Canada, Costa Rica, India, Mexico, Netherlands, Philippines, Singapore and United Arab Emirates. |
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 = FPA
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