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, Sterile EO, Rx Only, Catalog #: a) KIT-075-02; b) KIT-075-03

Class I - Dangerous

🏥 Medical Devices Recalled: May 2, 2018 Galt Medical Other Medical Devices

What Should You Do?

Check if you have this product:
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
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Galt Medical Corporation
Reason for Recall:: 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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

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, Sterile EO, Rx Only, Catalog #: a) KIT-075-02; b) KIT-075-03

Product Codes/Lot Numbers:

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