FDAClass IIOctober 31, 2018

CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN recall: Sterility Concern

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

Why was CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: :W72118 Exp Date:7/1/2021

Product
CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 1231-080XL GOWN, SURGICAL XXL 1231-150XL GOWN, SURGICAL XXL
Recalling firm
Custom Healthcare Systems, Inc.
Quantity
89 units
Distribution
Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
Recall date
October 31, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls