1) TVS LPA recall: Endotoxin
1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10; d) KIT-071-11; 2) Enhance Transcarotid/Peripheral Access Kit…
Why was 1) TVS LPA recalled?
The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
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 #: 1) a) G18046082, G18046083, G18046084, G18046085; b) G18031106, G18031199, G18046076; c) G18030048, G18030049; d) G18030050, G18030204; 2) a) G18003035, G18101170; b) G18003036, G18003037, G18003038
- Product
- 1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10; d) KIT-071-11; 2) Enhance Transcarotid/Peripheral Access Kit…
- Recalling firm
- Galt Medical Corporation
- Quantity
- 8350
- Distribution
- U.S.: MN, PA, VA, CA, UT, FL, NY, GA, LA, MO, TX, MS, OH, WA, MA, IL, KY, NC, and Puerto Rico; OUS: Canada, Australia, France, Germany, Ireland, Italy, Netherlands, Poland, Slovakia, Switzerland, Belgium, United Kingdom, Korea
- Recall date
- August 8, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)