Recall Z-1233-2017— Degania Silicone, Ltd.
Class II · Terminated
Class II FDA medical device recall by Degania Silicone, Ltd., initiated 2017-01-31, terminated 2017-04-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Distributed by Cardinal Health, USA Catalog Number: JP-2187 For wound drainage.. Reason: Product sterility compromised due to breach of sterile barrier.
- Recalling firm
- Degania Silicone, Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-01-31
- Terminated
- 2017-04-04
- Firm location
- Dganya Bet, N/A, Israel
Product description
Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Distributed by Cardinal Health, USA Catalog Number: JP-2187 For wound drainage.
Reason for recall
Product sterility compromised due to breach of sterile barrier
Data sourced from openFDA. This site is unofficial and independent of the FDA.