Z-0265-2019Class II

CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 1231-080XL GOWN, SURGICAL XXL...

Name: Z-0265-2019 CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 1231-080XL GOWN, SURGICAL XXL...
Creator: Custom Healthcare Systems, Inc.
Published: 2018-08-13
License: https://open.fda.gov/license/

Manus Medical, LLC / initiated 2018-08-13 / Terminated / root cause: packaging

FDA source

Custom Healthcare Systems, Inc. began a recall of CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 1231-080XL GOWN, SURGICAL XXL 1231-150XL GOWN, SURGICAL XXL on 2018-08-13. FDA classified it as Class II and gives the reason as "Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0265-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-13
Posted: 2018-10-25
Terminated: 2022-08-01
Recalling firm: Manus Medical, LLC
Product: CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 1231-080XL GOWN, SURGICAL XXL 1231-150XL GOWN, SURGICAL XXL
Product code: LRO General Surgery Tray
Reason for recall: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Root cause tag: packaging
FDA root cause: Packaging
Action: Custom Healthcare Systems (CHS) initiated recall by phone, email and by certified mail on 8/13/18 and carried out to the end user. Custom Healthcare Systems Inc. notified the customers, they were informed to contact their account to receive the product. Product to be returned and credited.
Quantity in commerce: 89 units
Distribution: Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
Product codes and lots: Lot Number: :W72118 Exp Date:7/1/2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0265-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0240-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0241-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0242-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0243-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0244-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0245-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0246-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0247-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0248-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0249-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0250-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0251-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0252-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0253-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0254-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0255-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0256-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0257-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0258-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0259-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0260-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0261-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0262-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0263-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0264-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0265-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0266-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0267-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0268-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25

Product code LRO

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)