Churchill Medical AMS-530 Microbore Extension Sets Recalled for Leaking
Churchill Medical Systems is recalling AMS-530 Microbore Trifurcated Extension sets because a defective component may cause the sets to leak.
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 medical device with a defect that may cause leaking, which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Churchill Medical Systems, Inc. is recalling 3,850 units of AMS-530 7 Microbore Trifurcated Extension sets. These products are intravascular administration sets used for medical purposes.
The recall was initiated because a defective component may cause the extension sets to leak. The affected units are identified by Lot Numbers 1306034 and 1307011.
The products were distributed nationwide in the states of New York, Virginia, Illinois, Missouri, Oregon, Florida, Delaware, and Ohio. Consumers and healthcare facilities should stop using the affected products and contact the manufacturer for further instructions.
The recalled product
- Product
- AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration set.
- Manufacturer
- Churchill Medical Systems, Inc.
- Hazard
- Affected units
- 3,850
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 (2)
- Lot Number: 1306034
- 1307011
Distribution
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