FDA Device recall Z-2558-2018
1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04
- FDA Device
- Class II
- terminated
- Published 2018-08-08
On 2018-08-08 the FDA classified a Class II recall of 1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04 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-2558-2018 |
| 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) 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;
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) S18015025; b) S18015026, c) S18015027; d) S18046198; 2) a) G17356364; 3) a) S18016057, S18106396, b…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; |
|---|
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-2558-2018%22
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