FDAClass IIOctober 31, 2018

CHS Custom Convenience Kit-BONE MARROW TRAY Product recall: Sterility Concern

CHS Custom Convenience Kit-BONE MARROW TRAY Product Number:B9-4000

Why was CHS Custom Convenience Kit-BONE MARROW TRAY Product 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: 61518 Exp Date: 12/1/2020

Product
CHS Custom Convenience Kit-BONE MARROW TRAY Product Number:B9-4000
Recalling firm
Custom Healthcare Systems, Inc.
Quantity
48 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)
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