Recall Z-3235-2017 ยท MMP Cover, Barrier, Protective
NOVADAQ TECHNOLOGIES INC.
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 co
| Date | Jun 27, 2017 |
| Status | Terminated |
| Reason | The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm, Novadaq, issued an "URGENT DEVICE RECALL" letter dated 6/15/2017 via delivery by firm sales representatives or courier service (such as FedEx or UPS) on 6/27/2017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to return unused product to Novadaq representative and complete and return the Acknowledgement of Receipt form by email to Novadaq Quality Department at quality@novadaq.com within 24 hours of receipt. Any questions or concerns may also be sent the listed email address. If you have any questions, pl |
| Quantity | 16/6-drape kits |
| Distribution | Worldwide Distribution. US (nationwide) to states of: CA, CO, ID, IL, NY, OR, and VA; and countries of: Canada, Belgium, and Lithuania. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041501 | GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS Guangzhou Fortunique , Ltd., Nov 30, 2004 |