Elcam Minimal Residual Volume Stopcock Recalled for Punctures
Elcam Medical, Inc. is recalling 810 units of Minimal Residual Volume Luer-activated Swabable-stockcock devices found to have punctures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II, and the defect (punctures in an IV stopcock) presents a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Elcam Medical, Inc. is recalling 810 units of the Minimal Residual Volume Luer-activated Swabable-stockcock (MRVLS) 4w gxl:w1/r rbls. The recall is limited to Lot #1670350901, which was distributed nationwide in the United States.
The recall was initiated because the stopcock devices were found to have punctures. These devices are indicated for fluid flow directional control and providing access ports for the administration of intravenous solutions, including pressure monitoring and transfusion.
Healthcare facilities and consumers should stop using the affected devices and contact Elcam Medical, Inc. for instructions on return or replacement.
The recalled product
- Product
- Elcam Minimal Residual Volume Luer-activated Swabable-stockcock (MRVLS) 4w gxl:w1/r rbls Product Usage: indicated for fluid flow directional control and for providing access ports for administration of intravenous solutions. Typical uses include pressure monitoring…
- Manufacturer
- Elcam Medical, Inc.
- Category
- Medical Device — IV Stopcock
- Affected units
- 810
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 (1)
- Lot #1670350901
Distribution
Distributed nationwide across the United States.
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