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U.S. Department of Health and Human Services

Class 2 Device Recall NOVADAQ SPYPHI

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  Class 2 Device Recall NOVADAQ SPYPHI see related information
Date Initiated by Firm June 27, 2017
Create Date September 28, 2017
Recall Status1 Terminated 3 on December 11, 2017
Recall Number Z-3236-2017
Recall Event ID 77901
510(K)Number K041501  
Product Classification Cover, barrier, protective - Product Code MMP
Product NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH 2020 (box of 20 HH2000 drapes), Sterile, Rx.. Manufactured for: Novadaq Technologies Inc., Burnaby, BC, Canada.

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 Lots #1703291, #1704141, and #1704101
Recalling Firm/
Manufacturer		 NOVADAQ TECHNOLOGIES INC.
8329 Eastlake Dr Unit 101
Burnaby Canada
For Additional Information Contact Jen Pendlebury
905-629-3822 Ext. 205
Manufacturer Reason
for Recall		 The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
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 3/20-drape boxes
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
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.
510(K) Database 510(K)s with Product Code = MMP and Original Applicant = GUANGZHOU FORTUNIQUE LTD.
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