1. Femoral Canal Pressurizer without Hub recall: Sterility Concern
1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000, UDI: (01)4546540039552; 2. Femoral Canal Pressurizer without…
Why was 1. Femoral Canal Pressurizer without Hub recalled?
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
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?
Lot Number (Medium): 17276012; Lot Number (Large): 17282012 UDI: (01)4546540039552; (01)4546540039569
- Product
- 1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000, UDI: (01)4546540039552; 2. Femoral Canal Pressurizer without…
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Quantity
- 444
- Distribution
- Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
- Recall date
- April 4, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)