Z-2558-2018Class II

1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04; b)...

Name: Z-2558-2018 1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04; b)...
Creator: Galt Medical Corporation
Published: 2018-05-02
License: https://open.fda.gov/license/

Galt Medical Corp / initiated 2018-05-02 / Terminated / root cause: sterility

FDA source

Galt Medical Corporation began a recall of 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... on 2018-05-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2558-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-02
Posted: 2018-07-27
Terminated: 2020-07-20
Recalling firm: Galt Medical Corp
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;
Product code: DYB Introducer, Catheter
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.
Root cause tag: sterility
FDA root cause: Other
Action: On approximately 05/01/2018 recall letters and customer response forms were mailed to all consignees.
Quantity in commerce: 3160
Distribution: U.S.: MN, PA, VA, CA, UT, FL, NY, GA, LA, MO, TX, MS, OH, WA, MA, IL, KY, NC, and Puerto Rico; OUS: Canada, Australia, France, Germany, Ireland, Italy, Netherlands, Poland, Slovakia, Switzerland, Belgium, United Kingdom, Korea
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2558-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2558-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-27
Z-2559-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-27
Z-2560-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-27
Z-2561-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-27
Z-2562-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-27
Z-2563-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-27
Z-2564-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-27
Z-2565-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-27

Product code DYB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)