FDA Medical Device Recalls (openFDA)
Stradis Healthcare: VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS
- Recall number
- Z-1688-2022
- Recalling firm
- Stradis Healthcare
- Product
- VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS
- Status
- Open, Classified
- Initiated
- 2022-05-10
- Posted
- not on file
- Terminated
- not on file
- Reason
- Potential for incomplete seals.
- Root cause
- Other
- Action
- 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.
- Quantity
- 520 units
- Distribution
- Pennsylvania
- Lot, serial or model codes
- Part Number AMS-8465CS, UDI/DI: 00849884005622, Lot Number: 220614962, Expiration Date: 04/30/2023
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OXQ
- Firm FEI
- 1450943
- Firm city
- Waukegan
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28