Novadaq SPY-PHI Drape Recall Due to Potential Sterile Barrier Breach
Novadaq is recalling SPY-PHI Drapes because pinholes may compromise the sterile barrier. The product is used to cover surgical equipment, not patients.
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 specific lots of the SPY-PHI Drape, a sterile medical device intended to cover the SPY-PHI System to maintain a sterile field during surgery or other medical procedures. The product is not intended for patient contact.
The recall is being issued because the sterile drape material may contain a pinhole that compromises its integrity, resulting in a breach of the sterile barrier. This defect could potentially allow contamination of the equipment covered by the drape.
The affected product is the SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH 2020, sold in boxes of 20. The recall involves three specific lot numbers: #1703291, #1704141, and #1704101. The product was distributed worldwide, including in the United States (California, Colorado, Idaho, Illinois, New York, Oregon, and Virginia) and in Canada, Belgium, and Lithuania. Healthcare facilities should check their inventory for these specific lot numbers and stop using the product if found.
The recalled product
- 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 th
- 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)
- Lots #1703291
- #1704141
- and #1704101
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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