—#100642

Product

***REF 66800694***Qty 10***smith&nephew***RENASYS Port Foam Dressing Kit Port***STERILE***Rx Only.***Made in Mexico for/Fabrique au Mexique pour: Smith & Nephew, Inc., St. Petersburg, FL 33716***Smith & Nephew Medical Limited Hull HU3 2BN England***Lot 123456. Product Usage: The product is a suction device used as an accessory to the foam dressing kits, which is used in conjunction with Smith & Nephew Negative Pressure Wound Therapy (NPWT) systems to deliver negative pressure to a wound.

FDA product code: OMP — Negative Pressure Wound Therapy Powered Suction Pump
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K082211
Affected lot / code info: Product Code Number: 66800694 Lot numbers: 50512962, 50512969, 50512974, 50513087, 50514672, 50513073, 50513074, 50517647, 50516110, 50539644, 50539645, 50539646, 50539647, 50555348, 50555349, 50555351, 50539648, 50546339, 50546340, 50548244, 50548245, 50548246, 50548247 and 50548248.

Why it was recalled

On 12/14/2010, Smith & Nephew, Inc. Wound Management Division in St. Petersburg, FL recalled their RENASYS PORT product code number 66800694 due to small holes in the primary pouch of some of the packaged units of which constituted a breach of the sterile barrier.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Smith & Nephew, Inc., Wound Management sent an URGENT DEVICE RECALL letter dated December 14, 2010, to all affected customers. The letter identified the product, problem, and actions to be taken. Customers were instructed to immediately identify and isolate the recalled lots in their inventory, complete and fax the response form, and return any affected products to APL Logistics, Inc. in Suwanee, GA. For questions in general, please contact the Customer Care Center at 1-800-876-1261.

Recalling firm

Firm: Smith & Nephew Inc.
Address: 970 Lake Carillon Dr, Ste 110, Saint Petersburg, Florida 33716-1130

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) including the states of: AZ, CA, GA, MA, MI, MO, MS,.NC, NY,OR, TN, and WI. and the countries of: Australia, Canada, China, England, Germany, Ireland and Singapore.

Timeline

Recall initiated: 2010-12-14
Posted by FDA: 2012-01-26
Terminated: 2012-04-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #100642. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.