Novadaq Spy-phi Drape recall: Sterility Concern
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.…
Why was Novadaq Spy-phi Drape 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?
Lots #1703291, #1704141, and #1704101
- 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.…
- Recalling firm
- NOVADAQ TECHNOLOGIES INC.
- Quantity
- 3/20-drape boxes
- 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)