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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lots #1703291, #1704141, and #1704101
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- NOVADAQ TECHNOLOGIES INC.
- Reason for Recall:
- The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
Lots #1703291, #1704141, and #1704101
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-3236-2017
Related Recalls
The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
Novadaq is informing SK6000 PAQ users that a pinhole through the drape pouch film material was identified in some SK6000 PAQs during shipping validation testing.