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Hemo-Cath®
Medical Components, Inc. · Model SL15CIJ · UDI-DI 00884908045321
LFJ
Prescription
10
510(k) clearances
2,170
Adverse events (140 deaths)
6
Recalls
23
Facilities
Description
11.5F X 15CM Hemo-Cath® SILICONE DOUBLE LUMEN IJ CATHETER
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-21 | ARROW INTERNATIONAL, LLC | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited repo |
| 2019-03-13 | Medical Components, Inc dba MedComp | Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer. |
| 2019-03-13 | Medical Components, Inc dba MedComp | Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer. |
| 2019-03-13 | Medical Components, Inc dba MedComp | Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer. |
| 2019-03-13 | Medical Components, Inc dba MedComp | Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer. |
| 2015-01-21 | Medical Components, Inc dba MedComp | Drug products contained within the kits may have been rendered ineffective by a duplicate sterilization process. The kits include one or more of the following drugs: 5ml ampule |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.