Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
General Hospital · 21 CFR 880.5440
Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting.
Recent MDR events
4,732 adverse event reports on file
- BD PhasealJul 31, 2026MalfunctionBecton Dickinson, S.a.3003152976-2026-00345
- BD PhasealJul 31, 2026MalfunctionBecton Dickinson, S.a.3003152976-2026-00346
- BD Phaseal OptimaJul 31, 2026MalfunctionBecton Dickinson, S.a.3003152976-2026-00347
- BD Phaseal OptimaJul 31, 2026MalfunctionBecton Dickinson, S.a.3003152976-2026-00348
- 8" (20 cm) Ext Set w/MicroClave® Clear, ChemoLock¿ Port, Y-Connector, Rotating LJul 30, 2026MalfunctionIcu Medical De Mexico, S. De R.l. De C.v.9617594-2026-00954
- BD PhasealJul 30, 2026MalfunctionBecton Dickinson2243072-2026-00541
- Spiros®, Closed Male Luer w/Red Cap, 10 UnitsJul 28, 2026MalfunctionIcu Medical De Mexico, S. De R.l. De C.v.9617594-2026-00947
- Spinning Spiros® Closed Male Luer, 10 unitsJul 28, 2026MalfunctionIcu Medical De Mexico, S. De R.l. De C.v.9617594-2026-00952
- Spinning Spiros® Closed Male Luer, Red CapJul 27, 2026MalfunctionIcu Medical De Mexico, S. De R.l. De C.v.9617594-2026-00923
- Spinning Spiros® Closed Male Luer, Red CapJul 27, 2026MalfunctionIcu Medical De Mexico, S. De R.l. De C.v.9617594-2026-00925
Event type breakdown
Recalls
71 recall events for this product code
- ICU Medical, Inc.Open, ClassifiedMay 18, 2026
Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, Che
Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.
Z-2210-2026 · View FDA record ↗ - ICU Medical, Inc.Open, ClassifiedOct 27, 2025
ChemoLock Bag Spike, 01 units
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Z-0328-2026 · View FDA record ↗ - ICU Medical, Inc.Open, ClassifiedOct 27, 2025
ICU Medical
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Z-0329-2026 · View FDA record ↗ - ICU Medical, Inc.Open, ClassifiedOct 27, 2025
ICU Medical
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Z-0330-2026 · View FDA record ↗ - ICU Medical, Inc.Open, ClassifiedOct 27, 2025
ICU Medical
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Z-0331-2026 · View FDA record ↗ - ICU Medical, Inc.Open, ClassifiedOct 27, 2025
ICU Medical
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Z-0332-2026 · View FDA record ↗ - ICU Medical, Inc.Open, ClassifiedOct 27, 2025
ICU Medical
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Z-0333-2026 · View FDA record ↗ - ICU Medical, Inc.Open, ClassifiedOct 27, 2025
ICU Medical
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Z-0334-2026 · View FDA record ↗ - ICU Medical, Inc.Open, ClassifiedOct 27, 2025
ICU Medical
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Z-0335-2026 · View FDA record ↗ - ICU Medical, Inc.Open, ClassifiedOct 27, 2025
ICU Medical
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Z-0336-2026 · View FDA record ↗
Registered firms
128 firms currently registered for this product code
Icu Medical, Inc.
Lake Forest, IL, US
Becton Dickinson, S.a.
SAN AGUSTIN DE GUADALIX Madrid (Province), ES
Nextphase Medical Devices Mexico Llc
TIJUANA Baja California, MX
Becton Dickinson
FRANKLIN LAKES, NJ, US
Carefusion 2200, Inc.
Vernon Hills, IL, US
Epic International (thailand) Co., Ltd.
Amphur Pluakdaeng Rayong, TH
Sky Medical, A.s.
Samorin Trnavsky, SK
Bd Switzerland Sarl
Eysins Vaud, CH
Cbr Enterprise Limited
Hong Kong, HK
Equashield Llc
Port Washington, NY, US
Sistemas Medicos Alaris, S.a De C.v.
TIJUANA Baja California, MX
Ad Supply Group Limited
London London, City of, GB
Sanicure Bv
SCHIPHOL Noord-Holland, NL
Mediplast Israel Ltd
Yavne Tel Aviv, IL
Sor Van Radiation Ltd
Yavne Tel Aviv, IL
Bd European Distribution Center
Temse Oost-Vlaanderen, BE
Icu Medical De Mexico, S. De R.l. De C.v.
ENSENADA, Baja California, MX
Icu Medical, Inc
Salt Lake City, UT, US
510(k) clearances
41 clearances for this product code
- Epic Medical Pte. , Ltd.Dec 5, 2025
K251722 · ProSeal Transfer Injector (421120, 421130, 421140)
- Simplivia Healthcare , Ltd.Oct 21, 2025
K253033 · Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor
- Becton, Dickinson and CompanySep 12, 2025
K250059 · BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O)
- Simplivia Healthcare , Ltd.Aug 5, 2025
K251411 · Chemfort Female Luer Lock Adaptor
- Epic Medical Pte. , Ltd.May 29, 2025
K251340 · ProSeal Bag Spike with Additive Port (423370ST, 423370)
- Epic Medical Pte. , Ltd.Jan 22, 2025
K243976 · ZeroClear Bag Access (423100)
- Epic Medical Pte. , Ltd.Dec 26, 2024
K240517 · ProSeal Vented Universal Vial Adaptor
- Epic Medical Pte. , Ltd.Oct 23, 2024
K241988 · ProSeal Closed System Bag Access