Z-3236-2017 Class II Terminated
FDA device recall Z-3236-2017 was initiated by NOVADAQ TECHNOLOGIES INC. on June 27, 2017 and is designated Class II. Reason for recall: The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier. The recall status is terminated (terminated December 11, 2017). Affected quantity: 3/20-drape boxes.
Recall Details
- Product Type
- Devices
- Report Date
- October 4, 2017
- Initiation Date
- June 27, 2017
- Termination Date
- December 11, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3/20-drape boxes
Product Description
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.
Reason for Recall
The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
Distribution Pattern
Worldwide Distribution. US (nationwide) to states of: CA, CO, ID, IL, NY, OR, and VA; and countries of: Canada, Belgium, and Lithuania.
Code Information
Lots #1703291, #1704141, and #1704101