FDAClass IIApril 26, 2017

Surestep Tray recall

SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile.

Why was Surestep Tray recalled?

Misbranded: Product labeled, Not made with natural rubber latex, may in fact contain natural rubber latex.

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?

Product Code: A300316A, Lot number: NGAV2400

Product
SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile.
Recalling firm
C.R. Bard, Inc.
Quantity
5030 units
Distribution
CA, CO, FL, GA, IA, IL, IN, KY, LA, MI, MN, MS, NC, NE, NJ, NM, OH, OR, PA, RI, TN, TX, VA and WA.
Recall date
April 26, 2017
Classification
Class II
Status
Completed
Agency
FDA (device)
Open FDA enforcement record Latest recalls