Z-1688-2022Class II

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

Name: Z-1688-2022 VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS
Creator: Stradis Healthcare
Published: 2022-05-10
License: https://open.fda.gov/license/

Gyn-Disposables, Inc. / initiated 2022-05-10 / Open, Classified

FDA source

Stradis Healthcare began a recall of VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS on 2022-05-10. FDA classified it as Class II and gives the reason as "Potential for incomplete seals". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1688-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-05-10
Posted: 2022-09-08
Recalling firm: Gyn-Disposables, Inc.
Product: VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS
Product code: OXQ Dressing Change Tray
Reason for recall: Potential for incomplete seals.
FDA 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 in commerce: 520 units
Distribution: Pennsylvania
Product codes and lots: Part Number AMS-8465CS, UDI/DI: 00849884005622, Lot Number: 220614962, Expiration Date: 04/30/2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1688-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1688-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-08

Product code OXQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)