FDAClass IIAugust 29, 2012

CMS-8934 Custom Phlebectomy Tray recall: Sterility Concern

CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 mL, Manufactured by: CMS, Custom Medical Specialties, Inc., 330 East Main…

Why was CMS-8934 Custom Phlebectomy Tray recalled?

Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags.

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 #: 25915-1111, Exp 12/2012

Product
CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 mL, Manufactured by: CMS, Custom Medical Specialties, Inc., 330 East Main…
Recalling firm
Custom Medical Specialties, Inc.
Quantity
20 Trays
Distribution
GA, MD, MA
Recall date
August 29, 2012
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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