Reported Aug 8, 2018 · Terminated
1) Drainer Centesis Catheter, 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) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #
8 of 8 products
| # | Product as published |
|---|---|
| 1 | DRC-001-05 |
| 2 | DRC-001-06 |
| 3 | DRC-001-15 |
| 4 | Centeze Centesis Catheter, Sterile EO, Rx Only, Catalog # |
| 5 | DRC-002-02 |
| 6 | DRC-002-05 |
| 7 | DRC-002-06 |
| 8 | DRC-002-08 |
- Lot codes and dates
7 of 7 products
Products covered by this recall # Product as published 1 a) 18037128, 18057123 2 18026062, 18026063 3 18050076, 18092077 4 a) 17303409, 17313728, 17324971, 17324972, 17340309, 17340310, 17355684 5 17303412, 17311642, 17335910, 17340312, 17340314, 17355685, 17355686, 17355687 6 17311643, 17314335, 17349257, 18026356, 18033604, 18047978, 18096513, 18110747 7 17314337, 17321338, 17352567, 18005181 - Amount recalled
- 13210
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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