Z-3235-2017Class II

NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006, containing 6...

Name: Z-3235-2017 NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006, containing 6...
Creator: Novadaq Technologies Inc.
Published: 2017-06-27
License: https://open.fda.gov/license/

Novadaq Technologies ULC / initiated 2017-06-27 / Terminated / root cause: packaging

FDA source

NOVADAQ TECHNOLOGIES INC. began a recall of 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... on 2017-06-27. FDA classified it as Class II and gives the reason as "The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-3235-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-27
Posted: 2017-09-28
Terminated: 2017-12-11
Recalling firm: Novadaq Technologies ULC
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.
Product code: MMP Cover, Barrier, Protective
Reason for recall: The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
Root cause tag: packaging
FDA root cause: 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 [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].
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.
Product codes and lots: PAQ lot #1704B containing drape lot #1703251; PAQ lot #1704F containing drape lot #1703291; and PAQ lot #17046 containing drape lot #1703251.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3235-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3234-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-28
Z-3235-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-28
Z-3236-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-28

Product code MMP

K041501Class IIGuangzhou Fortunique Drapes, Bags and CoversGuangzhou Fortunique , Ltd. / cleared 2004-11-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)