FDAClass IIApril 6, 2016

IMCO brand Conforming Stretch Gauze Bandages recall: Sterility Concern

IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6 86864 04351 5, 96 per case (8 boxes x 12…

Why was IMCO brand Conforming Stretch Gauze Bandages recalled?

Product does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus.

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 63927, expiration 2017-04

Product
IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6 86864 04351 5, 96 per case (8 boxes x 12…
Recalling firm
Amd Ritmed
Quantity
126 cases total (87 cases domestically and 39 cases internationally)
Distribution
US Distribution including Puerto Rico and to the states of : DE, FL, KY, MI, NE and NJ., and Internationally to the country of Canada.
Recall date
April 6, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls