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Portex

ICU MEDICAL, INC. · Model A3636-22 · UDI-DI 20351688074635

CAZ Prescription
1
510(k) clearances
5,152
Adverse events (5 deaths)
220
Recalls
81
Facilities

Recalls

DateFirmReason
2026-04-27Becton Dickinson & CompanyThis is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identifi
2026-04-27Becton Dickinson & CompanyThis is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identifi
2026-04-27Becton Dickinson & CompanyThis is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identifi
2026-04-27Becton Dickinson & CompanyThis is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identifi
2026-04-27Becton Dickinson & CompanyThis is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identifi
2026-04-27Becton Dickinson & CompanyThis is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identifi
2026-04-27Becton Dickinson & CompanyThis is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identifi
2026-04-27Becton Dickinson & CompanyThis is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identifi
2026-04-27Becton Dickinson & CompanyThis is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identifi
2026-04-27Becton Dickinson & CompanyThis is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identifi

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Data 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.