Facility

Advanced Medical Solutions Ltd

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

1inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3003080333
Establishment type	Manufacture Medical Device
Location	Premier Park, 33 Road One WINSFORD Cheshire East, GB CW7 3RT
Registration status	Active · expires 2026
Parent company	ADVANCED MEDICAL SOLUTIONS GROUP PLC (owner-operator 9031453)
Brand names	ActivHeal Aquafiber® Extra Ag; McKesson Gelling Fiber Dressing Ag

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (1)

Dressing, Wound, Drug
Product code FRO (opens in a new tab) · Unclassified · Unknown

Recalls & enforcement

Class IIOngoing2024-10-01
Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
Class IITerminated2015-01-15
On 08 January 2015 AMS Sole Customer for the products notified AMS of the issue after discovering the misplaced IFUs during its review of packaging in its warehouse

FDA inspections (1)

VAI2016-06-23
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Advanced Medical Solutions Ltd (FEI 3003080333) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003080333-advanced-medical-solutions-ltd/

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