NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH2000 (single drape), 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.
FDA Recall Z-3234-2017 · Posted None
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Recalling FirmNOVADAQ TECHNOLOGIES INC.
Recall StatusTerminated
Product CodeMMP
Date Initiated2017-06-27
Date Terminated2017-12-11
Product Quantity6 drapes
Reason for Recall
The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
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 [email protected] 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: [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide Distribution. US (nationwide) to states of: CA, CO, ID, IL, NY, OR, and VA; and countries of: Canada, Belgium, and Lithuania.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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