FDA Device recall Z-3234-2017
NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref
- FDA Device
- Class II
- terminated
- Published 2017-10-04
On 2017-10-04 the FDA classified a Class II recall of NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref by Novadaq Technologies, citing the sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3234-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-27 |
| Published | 2017-10-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Novadaq Technologies |
| Distribution | US |
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.
Identifiers
| code_info | Lot number 1704121 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3234-2017%22
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