FDAClass IIOctober 15, 2014

Renasys Ez/ Renasys EZ Plus recall

RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of…

Why was Renasys Ez/ Renasys EZ Plus recalled?

RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.

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?

Item 66800058 Lot # M400021 & Item 66800913 Lot # M400067

Product
RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of…
Recalling firm
Smith & Nephew, Inc.
Quantity
19,499 = (10,849 (Item 66800058) & 8,650 (Item 66800913))
Distribution
Worldwide Distribution - US Nationwide in the states of FL, NC, CA, MO, MA, TX, NY, OH, CO, VA, IL, NJ, TN, NV, MN including Puerto Rico and countries of Canada, Mexico, Dubai, Argentina, Australia, Colombia, Germany, Hong Kong, Jordon, Malaysia, Thailand, Tunisia, New Zealand, South Africa, Shanghai, Brazil, Saudi Arabia and Lebanon.
Recall date
October 15, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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