Device 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 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.
Z-3236-2017
Product summary
- Event
- Event 77901
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3/20-drape boxes
- Official record key
device-enforcement:Z-3236-2017
Official wording
Reason: The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
Code information: Lots #1703291, #1704141, and #1704101
Distribution pattern: Worldwide Distribution. US (nationwide) to states of: CA, CO, ID, IL, NY, OR, and VA; and countries of: Canada, Belgium, and Lithuania.
Derived failure modes
-
Sterility assurance
breach of the sterile barrier