Reported Aug 8, 2018 · Terminated
Tearaway Introducers, 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?
Tearaway Introducers, Catalog #
14 of 14 products
| # | Product as published |
|---|---|
| 1 | BNS-000-07 |
| 2 | BNS-000-10 |
| 3 | DIL-015-50 |
| 4 | DSS-005-11 |
| 5 | DSS-005-12 |
| 6 | DSS-006-045 |
| 7 | DSS-007-05 |
| 8 | DSS-007-165 |
| 9 | DSS-010-03 |
| 10 | DSS-010-04 |
| 11 | DSS-010-045 |
| 12 | DSS-010-05 |
| 13 | DSS-012-07 |
| 14 | SPT-003-46 |
- Lot codes and dates
14 of 14 products
Products covered by this recall # Product as published 1 18024880, 18043086, 18066833, 18073282 2 18039555, 18059249, 18074835 3 17363134 4 17352818, 18051601 5 18019228, 18047509 6 18023833 7 17356436, 18018694, 18018695, 18040074 8 18061579 9 18015027 10 18019038, 18029067, 18033068, 18075816, 18075817, 18075818 11 17363816, 18023834, 18026040, 18026072, 18033073, 18033079, 18054248 12 18005018, 18012032, 18012034, 18012035, 18012036, 18019037, 18026953, 18089355, 18096357, 18096358, 18103359 13 18047202 14 18054349 - Amount recalled
- 23777
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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