Stradis Healthcare VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS
Brand
Stradis Healthcare
Lot Codes / Batch Numbers
Part Number AMS-8465CS, UDI/DI: 00849884005622, Lot Number: 220614962, Expiration Date: 04/30/2023
Products Sold
Part Number AMS-8465CS, UDI/DI: 00849884005622, Lot Number: 220614962, Expiration Date: 04/30/2023
Stradis Healthcare is recalling VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS due to Potential for incomplete seals.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for incomplete seals.
Recommended Action
Per FDA guidance
Stradis notified its sole consignee initially by telephone on 05/10/2022 and followed with a letter disseminated by email on 05/11/2022. The letter explained the problem, risk to health, and requested the quarantine of the affected product pending return. The letter directed the consignee to notify their customers to whom they further distributed the product to return the product to Stradis.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PA
Page updated: Jan 10, 2026