ICU Medical Recalls Oncology and Administration Sets Due to Molding Defect
ICU Medical is recalling specific oncology and administration sets because a molding defect in male luers may cause leaks, potentially leading to fluid path contamination or exposure to hazardous medications.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, and the potential hazards include exposure to hazardous medications and fluid path contamination, fitting the 'High' severity criteria.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of oncology kits, administration sets, and extension sets. The recall involves 4,790 units of products including the 76 cm Admin Set, 44 cm PUR YELLOW TRANS SET, and various Oncology Kits with ChemoClave and Spiros components.
The recall is due to a molding defect in the spinning versions of male luers, which may exhibit leaks. This defect could potentially cause a delay in infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.
The affected products were distributed worldwide, including nationwide in the United States and in numerous international countries. The specific lot numbers affected are 4784390, 4784404, 4865931, 4865006, 4590283, 4774210, 4865952, 4711264, 4605516, 4723103, 4882016, and 4806569. Healthcare facilities and consumers should stop using these products and contact ICU Medical for further instructions.
The recalled product
- Product
- 76 cm (30") Appx 3.3 ml, Admin Set, 2 Spiros w/Red Cap, 20 Drop In-Line Drip Chamber w/15 Micron Filter, Bag Hanger, REF: 011-CH3261; 44 cm(17 IN) Appx 2.9 ml,PUR YELLOW TRANS SET,ChemoClave,CK VLV,Spiros,PURPLE CAP, REF: 011-CH3568; Oncology Kit, 5 Gang Stopcock w/5 ChemoClave,
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Infusion Sets
- Affected units
- 4,790
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- Lots: 4784390
- 4784404
- 4865931
- 4865006
- 4590283
- 4774210
- 4865952
- 4711264
- 4605516
- 4723103
- 4882016
- 4806569
Distribution
Part of a larger recall action
This product is one of 13 recalled by ICU Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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