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

Chs Custom Convenience Kit: 1231- Surgical Gown, Nrf W recalled

Custom Healthcare Systems is recalling Chs Custom Convenience Kit: 1231- Surgical Gown, Nrf W. Hand Towel 1231- Gown, Surgical, 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 codesLot Number: :W72118 Exp Date:7/1/2021

Quantity recalled89 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-0265-2019
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: Surgical Instruments

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: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 1231-080XL GOWN, SURGICAL XXL 1231-150XL GOWN, SURGICAL XXL

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

Why was it recalled?

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

Which lots are affected?

Lot Number: :W72118 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.

Other products in this recall event

28 other products · FDA event 81179

This product is part of a recall event; the main page for the event is Chs Custom Convenience Kit-Foerster Sponge Forceps, Serr recalled.

Reported	Class	Recall	Company	Reason	Where
31 Oct 2018	CLASS II	Chs Custom Convenience Kit-Foerster Sponge Forceps, Serr recalled	Custom Healthcare Systems	Sterility	9 states
31 Oct 2018	CLASS II	Chs Custom Convenience Kit-Bone Marrow Tray Product Number:B9 recalled	Custom Healthcare Systems	Sterility	9 states
31 Oct 2018	CLASS II	Chs Custom Convenience Kit-Cotton Tip Applicators, 10'S recalled	Custom Healthcare Systems	Sterility	9 states
31 Oct 2018	CLASS II	Chs Custom Convenience Kit-Suture Removal Kit #1 Product recalled	Custom Healthcare Systems	Sterility	9 states
31 Oct 2018	CLASS II	Chs Custom Convenience Kit- Penrose Drain recalled	Custom Healthcare Systems	Sterility	9 states
31 Oct 2018	CLASS II	Chs Custom Convenience Kit-Webster Needle Holder Product recalled	Custom Healthcare Systems	Sterility	9 states
31 Oct 2018	CLASS II	Chs Custom Convenience Kit-Toothbrush, 46 Tuft Product Number:R1635 recalled	Custom Healthcare Systems	Sterility	9 states
31 Oct 2018	CLASS II	Chs Custom Convenience Kit- Little Snipper Circumcision Tray recalled	Custom Healthcare Systems	Sterility	9 states
31 Oct 2018	CLASS II	Chs Custom Convenience Kit-Fenestrated Drape 40 X 62P recalled	Custom Healthcare Systems	Sterility	9 states
31 Oct 2018	CLASS II	Chs Custom Convenience 1231- Gown, Raglan, LG recalled	Custom Healthcare Systems	Sterility	9 states
31 Oct 2018	CLASS II	Chs Custom Convenience Kit-Suture Removal Kit recalled	Custom Healthcare Systems	Sterility	9 states
31 Oct 2018	CLASS II	Chs Custom Convenience Kit-General Utility Tray Product recalled	Custom Healthcare Systems	Sterility	9 states
31 Oct 2018	CLASS II	CHS Custom Convenience Kit- Coban¿, LF recalled	Custom Healthcare Systems	Sterility	9 states
31 Oct 2018	CLASS II	Chs Custom Convenience Kit-Mosquito Forceps 5 Str Product recalled	Custom Healthcare Systems	Sterility	9 states
31 Oct 2018	CLASS II	Chs Custom Convenience Kit-Rochester Pean, Curved recalled	Custom Healthcare Systems	Sterility	9 states
31 Oct 2018	CLASS II	Chs Custom Convenience Kit-Specialist¿ Cast Padding 3" X recalled	Custom Healthcare Systems	Sterility	9 states
31 Oct 2018	CLASS II	CHS Custom Convenience Kit-LP NEEDLEProduct Number:NC401000 recalled	Custom Healthcare Systems	Sterility	9 states
31 Oct 2018	CLASS II	CHS Custom Convenience Kit- DT Scatpad, DBL recalled	Custom Healthcare Systems	Sterility	9 states
31 Oct 2018	CLASS II	Chs Custom Convenience Kit-Toenail Removal Tray Product Number recalled	Custom Healthcare Systems	Sterility	9 states
31 Oct 2018	CLASS II	Chs Custom Convenience Kit-Injection Tray Product Number: B9 recalled	Custom Healthcare Systems	Sterility	9 states
31 Oct 2018	CLASS II	Chs Custom Convenience Kit-Pad, Cotton Single Product Number:R1178 recalled	Custom Healthcare Systems	Sterility	9 states
31 Oct 2018	CLASS II	Chs Custom Convenience Kit- Unc-vir Tray Product Number:Unc recalled	Custom Healthcare Systems	Sterility	9 states
31 Oct 2018	CLASS II	Chs Custom Convenience Kit-Connector Pack Product Number:D36 recalled	Custom Healthcare Systems	Sterility	9 states
31 Oct 2018	CLASS II	Chs Custom Convenience Kit-Surgical Gown recalled	Custom Healthcare Systems	Sterility	9 states
31 Oct 2018	CLASS II	CHS Custom Convenience Kit-DR recalled by Custom Healthcare Systems	Custom Healthcare Systems	Sterility	9 states
31 Oct 2018	CLASS II	CHS Custom Convenience Kit-Tubing W recalled	Custom Healthcare Systems	Sterility	9 states
31 Oct 2018	CLASS II	Chs Custom Convenience Kit-Vaginal Speculum recalled	Custom Healthcare Systems	Sterility	9 states
31 Oct 2018	CLASS II	Chs Custom Convenience Kit-Formula Cap (10'S Product Number recalled	Custom Healthcare Systems	Sterility	9 states

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

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Sterility	Nationwide