FDA Device Recall Z-0039-2015: Smith & Nephew, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0039-2015.

Recall Res Number

Z-0039-2015

Recalling Firm / Manufacturer

Smith & Nephew, Inc.

FEI Number

3006760724

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2014-07-18

Date Posted

2014-10-08

Date Terminated

2015-08-05

Product Code

OMP

Event Number

69146

Product Quantity

19,499 = (10,849 (Item 66800058) & 8,650 (Item 66800913))

Product Description 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 exudate removed from wounds being treated by negative pressure wound therapy (NPWT).

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

Action Details Smith & Nephew sent an Urgent Medical Device Correction Notice dated July 15, 2014 to all US customers via Federal Express delivery. The letter identified the affected product, problem and actions to be taken. The firm instructed customers to discard the affected product and replace with a new one from an unaffected lot. For questions contact 727-399-3785.

Distribution Pattern 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.

Code Information / Serial Numbers Item 66800058 Lot # M400021 & Item 66800913 Lot # M400067

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Medical Device Recall: Z-0039-2015

Recall Parameters & Description

Related Establishments / Registrations

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