Z-3235-2017 Class II Terminated
FDA device recall Z-3235-2017 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: 16/6-drape kits.
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
- 16/6-drape kits
Product Description
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.
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
PAQ lot #1704B containing drape lot #1703251; PAQ lot #1704F containing drape lot #1703291; and PAQ lot #17046 containing drape lot #1703251.