Recall Z-3234-2017— NOVADAQ TECHNOLOGIES INC.
Class II · Terminated
Class II FDA medical device recall by NOVADAQ TECHNOLOGIES INC., initiated 2017-06-27, terminated 2017-12-11. It names one FDA 510(k) clearance: K041501. 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 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.. Reason: The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier..
- Recalling firm
- NOVADAQ TECHNOLOGIES INC.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-27
- Terminated
- 2017-12-11
- Firm location
- Burnaby, N/A, Canada
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 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.
Reason for recall
The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
Data sourced from openFDA. This site is unofficial and independent of the FDA.