Facility

PRESERVATION SOLUTIONS, INC.

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

Key facts

1recalls · worst Class II

6inspections · worst OAI

1warning letters

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

FDA Establishment Identifier (FEI)	1000221028
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer); Manufacture Medical Device
Location	1099 Proctor Dr ELKHORN, WI, US 53121
Registration status	Active · expires 2026
Parent company	PRESERVATION SOLUTIONS, INC. (owner-operator 9010760)
Brand names	TAWT - TransAbdominal Wall Traction Device or StarGuard

Activity by year

Recalls (1)
Inspections (6)
Warning letters (1)

Devices registered here (1)

Retention Device, Suture
Product code KGS (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4930

Recalls & enforcement

Class IITerminated2018-02-26
Bags of solution may have a small leak at the base of the injection port where the port is welded into the body of the bag..

FDA inspections (6)

NAI2025-06-06
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
OAI2023-07-14
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
OAI2021-09-30
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
OAI2019-03-12
Official Action Indicated · Compliance: Devices · citations posted
VAI2018-08-10
Voluntary Action Indicated · Compliance: Devices · citations posted
OAI2017-05-19
Official 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.

FDA warning letters (1)

Warning Letter2017-08-21
Warning Letter (opens in a new tab) · Elkhorn Wisconsin

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

All facilities operated by PRESERVATION SOLUTIONS, INC.

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. “PRESERVATION SOLUTIONS, INC. (FEI 1000221028) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000221028-preservation-solutions-inc/

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