NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref recall — FDA Z-3234-2017
The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
Overview of recall records associated with Novadaq Technologies Inc., including dates, categories and classifications where available.
Classification mix: Class II: 5.
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.
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.
It has been determined that the PINPOINT Operator's Manual does not contain validated parameters for gravity-cycle autoclave sterilization of the PINPOINT laparoscopes and light guide cable…
This page summarizes recall records in which the official source identifies Novadaq Technologies Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.