NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI recall: Sterility Concern
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.
Why was NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI recalled?
The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
PAQ lot #1704B containing drape lot #1703251; PAQ lot #1704F containing drape lot #1703291; and PAQ lot #17046 containing drape lot #1703251.
- 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.
- Recalling firm
- NOVADAQ TECHNOLOGIES INC.
- Quantity
- 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.
- Recall date
- October 4, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)