1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04; b) BCL-100-05; c) BCL-100-06; d) BCL-500-36; 2) Elite HV Introducer Set, Sterile EO, Rx Only, Catalog #: a) CLI-105-14; 3) AngioGate HV Introducer Kit, Sterile EO, Catalog #: a) KCL-102-05; b) KCL-102-07 4) VSI Micro-HV Introducer Kit, Sterile EO, Catalog #: a) CLI-800-33; b) CLI-810-16;

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) S18015025; b) S18015026, c) S18015027; d) S18046198; 2) a) G17356364; 3) a) S18016057, S18106396, b) S18080265 4) a) S18032092, S18032093, S18032094; b) S18046163;
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) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04; b) BCL-100-05; c) BCL-100-06; d) BCL-500-36; 2) Elite HV Introducer Set, Sterile EO, Rx Only, Catalog #: a) CLI-105-14; 3) AngioGate HV Introducer Kit, Sterile EO, Catalog #: a) KCL-102-05; b) KCL-102-07 4) VSI Micro-HV Introducer Kit, Sterile EO, Catalog #: a) CLI-800-33; b) CLI-810-16;

Product Codes/Lot Numbers:

Lot #: 1) a) S18015025; b) S18015026, c) S18015027; d) S18046198; 2) a) G17356364; 3) a) S18016057, S18106396, b) S18080265 4) a) S18032092, S18032093, S18032094; b) S18046163;