Novadaq SPY-PHI Drape Recalled for Potential Sterile Barrier Breach
Novadaq is recalling SPY-PHI Drapes because pinholes may compromise the sterile barrier. The product is intended for equipment coverage, not patient contact.
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 is classified as FDA Class II and involves a risk of harm (sterile barrier breach) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Novadaq Technologies Inc. is recalling the SPY-PHI Drape, a sterile surgical drape used to cover the SPY-PHI System to maintain a sterile field. The recall is due to a potential defect where the drape material may contain a pinhole that compromises its integrity, resulting in a breach of the sterile barrier.
The affected product is the SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH2000 (single drape), sterile, prescription-only. The specific lot number is 1704121. The product was distributed worldwide, including in the United States (CA, CO, ID, IL, NY, OR, and VA), Canada, Belgium, and Lithuania. The drape is intended to cover the SPY-PHI System and aid in equipment clean-up; it is not intended for patient draping and has no patient contact.
Healthcare facilities and consumers should stop using the affected drapes and contact Novadaq Technologies Inc. for instructions on return or replacement. This recall is classified as Class II by the FDA.
The recalled product
- Product
- 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
- Manufacturer
- NOVADAQ TECHNOLOGIES INC.
- Category
- Medical Device — Surgical Drapes
- Hazard
- Affected units
- 6
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 (1)
- Lot number 1704121
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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