Recall Z-1688-2022— Stradis Healthcare

Class II · Ongoing

Class II FDA medical device recall by Stradis Healthcare, initiated 2022-05-10. FDA's recall record names no specific 510(k) clearance for this event. Product: VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS. Reason: Potential for incomplete seals..

Recalling firm
Stradis Healthcare
Classification
Class II
Status
Ongoing
Initiated
2022-05-10
Firm location
Waukegan, IL, United States

Product description

VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS

Reason for recall

Potential for incomplete seals.

Data sourced from openFDA. This site is unofficial and independent of the FDA.