FDA Medical Device Recalls (openFDA)
Smith & Nephew Inc.: ***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.
- Recall number
- Z-0875-2012
- Recalling firm
- Smith & Nephew Inc.
- 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.
- Status
- Terminated
- Initiated
- 2010-12-14
- Posted
- 2012-01-26
- Terminated
- 2012-04-30
- Reason
- 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
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 71329 units
- Distribution
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K082211"]
- PMA numbers
- not on file
- Product code
- OMP
- Firm FEI
- 3006760724
- Firm city
- Saint Petersburg
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28