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Class 2 Device Recall NOVADAQ SPYPHI PAQ |
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Date Initiated by Firm |
June 27, 2017 |
Create Date |
September 28, 2017 |
Recall Status1 |
Terminated 3 on December 11, 2017 |
Recall Number |
Z-3235-2017 |
Recall Event ID |
77901 |
510(K)Number |
K041501
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Product Classification |
Cover, barrier, protective - Product Code MMP
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Product |
NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006, containing 6 Single-Procedure Kits (Product Code HH9001), each containing the sterile drape (HH2000), as well as single-use drug components, Manufactured for and Distributed by Novadaq Technologies Inc., Burnaby, BC, Canada, Assembled by Carestream Health, Inc., Rochester, NY.
The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact. |
Code Information |
PAQ lot #1704B containing drape lot #1703251; PAQ lot #1704F containing drape lot #1703291; and PAQ lot #17046 containing drape lot #1703251. |
Recalling Firm/ Manufacturer |
NOVADAQ TECHNOLOGIES INC. 8329 Eastlake Dr Unit 101 Burnaby Canada
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For Additional Information Contact |
Jen Pendlebury 905-629-3822 Ext. 205
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Manufacturer Reason for Recall |
The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
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FDA Determined Cause 2 |
Under Investigation by firm |
Action |
The recalling firm, Novadaq, issued an "URGENT DEVICE RECALL" letter dated 6/15/2017 via delivery by firm sales representatives or courier service (such as FedEx or UPS) on 6/27/2017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to return unused product to Novadaq representative and complete and return the Acknowledgement of Receipt form by email to Novadaq Quality Department at quality@novadaq.com within 24 hours of receipt. Any questions or concerns may also be sent the listed email address.
If you have any questions, please do not hesitate to contact the Director of Regulatory Affairs at 1.905.629.3822 ext 205 or email: jpendlebury@novadaq.com. |
Quantity in Commerce |
16/6-drape kits |
Distribution |
Worldwide Distribution. US (nationwide) to states of: CA, CO, ID, IL, NY, OR, and VA; and countries of: Canada, Belgium, and Lithuania. |
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 = MMP and Original Applicant = GUANGZHOU FORTUNIQUE LTD.
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