0210-312-000-Woundcare Replacement kit with soft tip recall: Sterility Concern
0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit…
Why was 0210-312-000-Woundcare Replacement kit with soft tip recalled?
Potential sterility breach in the packaging.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
0210-312-000: 12138012, 12203012, 12229012, 12256012, 12293012, 12314012, 12338012, 13086012, 13140012, 13192012; 0210-318-000: 14140012,14258012; 0210-318-100: 12294012,13051012; 0210-318-200: 12143012, 12293012, 13066012, 14037012, 14112012
- Product
- 0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit…
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Quantity
- 5,328 each (444 boxes)
- Distribution
- Nationwide Distribution-including the states of FL, IA, IL, IN, LA, MD, MN, MO, NC, NM, NY, PA, TN, TX, VA, and WI.
- Recall date
- July 22, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)