FDA Device recall Z-2848-2016
RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film Is intended for patie…
- FDA Device
- Class II
- ongoing
- Published 2016-09-28
On 2016-09-28 the FDA classified a Class II recall of RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film Is intended for patie… by Smith And Nephew, citing sterility seal integrity failures on the Renasys Sterile Transparent Film.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2848-2016 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2016-07-21 |
| Published | 2016-09-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Smith And Nephew |
| Distribution | US |
Product
RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film Is intended for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wounds types include chronic, acute, traumatic, Sub-Acute and dehisced wounds, ulcers, (such as pressure and diabetic), partial thickness burns, flaps and grafts.
Reason
Sterility seal integrity failures on the Renasys Sterile Transparent Film
Identifiers
| code_info | Product Code 66020933 RENASYS G Small with Soft Port - Lots #'s 2015100134, 2015100313, 2015100314, 2016040686, and 201…Product Code 66020933 RENASYS G Small with Soft Port - Lots #'s 2015100134, 2015100313, 2015100314, 2016040686, and 2016040687 - US ONLY Product Code 66020934 RENASYS G Medium with Soft Port - Lots #'s 2015100135, 2015100315, 2015100316, 2015110540, 2016040715, and 2016040963 US ONLY Product Code 66020935 RENASYS G Large with Soft Port- Lots #'s 2015100282, 2015100317, 2015110542, and 2016041021 US ONLY Product Code 66020936 RENASYS G X Large with Soft Port Lot # 2016041035 US ONLY Product Code 66800394 RENASYS Transparent Film Lots #'s 2014010176, 2014011449, 2014030463, 2014040241, 2014050736, 2014051132, 2014061169, 2014113986, 2015020655, 2015040522, 2015050927, 015060209, 2015071095, 2015101044, 2015110749, 2015120664, and 2015121019 - GLOBAL Product Code 66800494 RENASYS G Medium Kit Flat Drain Lots #'s 02014P, 05014D, 06914E, 13414K, 15414T, 16014CV, 18114AV, 23214D, 25214J, and 26515H GLOBAL (NOT US) Product Code 66800495 RENASYS G Large Kit 19Fr Round Drain L |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2848-2016%22
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