Recall Z-2560-2018— Galt Medical Corporation
Class II · Terminated
Class II FDA medical device recall by Galt Medical Corporation, initiated 2018-05-02, terminated 2020-07-20. FDA's recall record names no specific 510(k) clearance for this event. Product: 1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b) DRC-001-06, c) DRC-001-15, 2) Centeze Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-002-02, b) DRC-002-05, c) DRC-002-06, d) DRC-002-08,. Reason: 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..
- Recalling firm
- Galt Medical Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-05-02
- Terminated
- 2020-07-20
- Firm location
- Garland, TX, United States
Product description
1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b) DRC-001-06, c) DRC-001-15, 2) Centeze Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-002-02, b) DRC-002-05, c) DRC-002-06, d) DRC-002-08,
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.