CLASS II Device recall · Reported 31 Oct 2018 · FDA Enforcement Report

CHS Custom Convenience Kit- DT Scatpad, DBL recalled

Custom Healthcare Systems is recalling CHS Custom Convenience Kit- DT Scatpad, DBL, distributed in 9 states. The recall was initiated on 13 Aug 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes(1)Lot Number:72018 Exp. Date: 7/1/2021 (2) Lot number: 71118 Exp. Date: 7/1/2021

Quantity recalled(1) 750 units (2) 200 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0242-2019
FDA event ID: 81179
Recalling firm: Custom Healthcare Systems, Richmond, VA
Classification: Class II
Status: Terminated
Recall initiated: 13 Aug 2018
FDA classified: 25 Oct 2018
Reported: 31 Oct 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

13 Aug 2018	Recall initiated by company
25 Oct 2018	Classified by FDA	+73 days
31 Oct 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34 Product Number: SPA502

Where it was distributed

Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,

Connecticut Georgia Illinois Kentucky Maryland North Carolina Oklahoma South Carolina Virginia

Questions about this recall

Is CHS Custom Convenience Kit- DT Scatpad, DBL recalled?

Yes. Custom Healthcare Systems recalled CHS Custom Convenience Kit- DT Scatpad, DBL on 13 Aug 2018. The recall is Class II and its status is Terminated. Recall number Z-0242-2019.

Why was it recalled?

Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility

Which lots are affected?

(1)Lot Number:72018 Exp. Date: 7/1/2021 (2) Lot number: 71118 Exp. Date: 7/1/2021

Where was it sold?

Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Custom Healthcare Systems

All 33

Reported	Class	Recall	Company	Reason	Where
5 Feb 2020Device	CLASS II	Inpatient Dialysis Kit PAK recalled by Custom Healthcare Systems	Custom Healthcare Systems	Other	IL
31 Oct 2018Device	CLASS II	Chs Custom Convenience Kit-Formula Cap (10'S Product Number recalled	Custom Healthcare Systems	Sterility	9 states
31 Oct 2018Device	CLASS II	Chs Custom Convenience Kit-Vaginal Speculum recalled	Custom Healthcare Systems	Sterility	9 states
31 Oct 2018Device	CLASS II	CHS Custom Convenience Kit-Tubing W recalled	Custom Healthcare Systems	Sterility	9 states
31 Oct 2018Device	CLASS II	CHS Custom Convenience Kit-DR recalled by Custom Healthcare Systems	Custom Healthcare Systems	Sterility	9 states

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