FDA Device recall Z-2561-2018
1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01
- FDA Device
- Class II
- terminated
- Published 2018-08-08
On 2018-08-08 the FDA classified a Class II recall of 1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01 by Galt Medical, citing the products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bac….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2561-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-02 |
| Published | 2018-08-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Galt Medical |
| Distribution | CA, FL, GA, IL, KY, LA, MA, MN, MO, MS, NC, NY, OH, PA, PR, TX, UT, VA, WA |
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, Sterile EO, Rx Only, Catalog #: a) KIT-075-02; b) KIT-075-03
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.
Identifiers
| code_info | Lot #: 1) a) G18046082, G18046083, G18046084, G18046085; b) G18031106, G18031199, G18046076; c) G18030048, G18030049;…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2561-2018%22
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