Reported Aug 8, 2018 · Terminated
1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #
Galt Medical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Galt Medical Corporation · 2220 Merritt Dr · Garland, TX · 75041-6137
Is this the product you have?
1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #
12 of 12 products
| # | Product as published |
|---|---|
| 1 | BCL-100-04 |
| 2 | BCL-100-05 |
| 3 | BCL-100-06 |
| 4 | BCL-500-36 |
| 5 | Elite HV Introducer Set, Sterile EO, Rx Only, Catalog # |
| 6 | CLI-105-14 |
| 7 | AngioGate HV Introducer Kit, Sterile EO, Catalog # |
| 8 | KCL-102-05 |
| 9 | KCL-102-07 |
| 10 | VSI Micro-HV Introducer Kit, Sterile EO, Catalog # |
| 11 | CLI-800-33 |
| 12 | CLI-810-16 |
- Lot codes and dates
Lot #: 1) a) S18015025b) S18015026c) S18015027d) S180461982) a) G173563643) a) S18016057S18106396b) S18080265 4) a) S18032092S18032093S18032094b) S18046163
- Amount recalled
- 3160
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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