| Class 2 Device Recall LifeShield Primary SYMBIQ Set | |
Date Initiated by Firm | January 08, 2010 |
Date Posted | February 22, 2010 |
Recall Status1 |
Terminated 3 on July 20, 2011 |
Recall Number | Z-0808-2010 |
Recall Event ID |
54195 |
510(K)Number | K041550 |
Product Classification |
Set, administration, intravascular - Product Code FPA
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Product | LifeShield Latex-Free Primary SYMBIQ Set, Piggyback with Backcheck Valve, 3 Prepierced Y-Sites, 106 inch, Non-DEHP, 15 drops/mL; an Rx sterile single use fluid path way for administration of I.V. fluids using the Symbiq infusion pump; 48 sets per case; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list number 16096-28. |
Code Information |
List Number: 16096-28, Lot: 82-028-5H |
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 | There is a potential for fluid to leak from the backcheck valve which could result in inaccurate delivery and occupational exposure. |
FDA Determined Cause 2 | Process control |
Action | Hospira Medical issued an "Urgent Device Recall" notification dated January 8, 2010 informing consignees of the affected product. The accounts were instructed to examine their inventory and quarantine affected product immediately and arrange for its return. Users were also requested to complete the enclosed reply form and return it to the firm.
For further information, contact Hospira Medical Communications at 1-800-615-0187. |
Quantity in Commerce | 47,904 sets |
Distribution | Minnesota and Utah |
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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