smith&nephew EZCARE Negative Pressure Rx only. 100-240 V 12 V 50/60 Hz 90VA T1A 250 V Indicated for patients who would benefit from a suction device particularly as the device may promote healing when used with accessory wound sealing kits. Made in USA by/Fabrique aux Etals Unis par: Smith & Nephew, Inc., Largo, FL 33773 Smith & Nephew Medical Limited Hull HU3 2BN England
FDA Recall Z-0310-2011 · Posted 2010-11-03
Recalling FirmSmith & Nephew Inc.
Recall StatusTerminated
Product CodeOMP
Date Initiated2010-01-29
Date Terminated2010-11-10
Product Quantity2717 units
Reason for Recall
Smith&Nephew Inc., Advance Wound Management, St Petersburg, FL is recalling their Ezcare Negative Pressure Wound Therapy pumps manufactured by BlueSky Medical Group Inc., between July 17, 2007 and December 13, 2007 and distributed by Smith&Nephew between July 18, 2007 and January 14, 2010. Affected products codes are 66800187, 66800322, 66800323, 66800324, and 66800325 with Serial Numbers startin
Firm Action
Smith & Nephew Inc. FEDEXed overnight an URGENT DEVICE RECALL letter dated January 27, 2010, to all customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were to check their inventory and identify any affected product, fill out and return the response form by both mail and fax, and return the affected product with the prepaid Federal Express (FedEx) Ground label provided by Smith & Nephew. For any questions regarding this recall contact the Customer Care Center at (800) 876-1261.
Root Cause
Other
Distribution Pattern
Worldwide Distribution - US including AL, AR, AZ, CA, GA, IL, IN, MA, MD, MD, MO, NC, NJ, NY, OH, OR, PA, TN, TX, and UT and the countries of Australia, UK, South Africa, Canada, Puerto Rico, and New Zealand.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.