Novadaq SPY-PHI PAQ Sterile Drape Recall Due to Pinholes
Novadaq is recalling SPY-PHI PAQ kits because pinholes in the sterile drape may compromise the sterile barrier. The product is used in medical procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile barrier breach) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Novadaq Technologies Inc. is recalling the NOVADAQ SPY-PHI PAQ, a medical device intended for use with the SPY-PHI System. The product consists of 6 Single-Procedure Kits, each containing a sterile drape and single-use drug components. The sterile drape is designed to cover the SPY-PHI System to maintain a sterile field during surgery or other medical procedures and is not intended for patient contact.
The recall is being issued because the sterile drape material may contain a pinhole that compromises its integrity. This defect could result in a breach of the sterile barrier, potentially exposing the surgical site or equipment to contamination. The affected product was distributed worldwide, including in the United States (CA, CO, ID, IL, NY, OR, VA), Canada, Belgium, and Lithuania.
Healthcare facilities and consumers should stop using the affected lots immediately. The specific lots involved are PAQ lot #1704B (drape lot #1703251), PAQ lot #1704F (drape lot #1703291), and PAQ lot #17046 (drape lot #1703251). Users should contact Novadaq Technologies for further instructions on returning or replacing the product.
The recalled product
- 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
- Manufacturer
- NOVADAQ TECHNOLOGIES INC.
- Category
- Medical Device — Surgical Drapes
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- PAQ lot #1704B containing drape lot #1703251
- PAQ lot #1704F containing drape lot #1703291
- and PAQ lot #17046 containing drape lot #1703251.
Distribution
Part of a larger recall action
This product is one of 3 recalled by NOVADAQ TECHNOLOGIES INC. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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