Teleflex Recalls Babi.Plus Pressure Relief Manifolds for Ventilators
Teleflex is recalling Babi.Plus 12.5 cm H2O Pressure Relief Manifolds because the devices vented gas below the stated pressure.
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 defect that could compromise ventilator safety, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Teleflex-Morrisville is recalling 9,312 units of the Babi.Plus 12.5 cm H2O Pressure Relief Manifold, Catalog # 2691. These medical devices are used with ventilators. The recall covers specific lots: 180806, 180910, 181029, 181105, 181204, 190225, and 190327.
The recall was initiated because the devices vented gas below the stated pressure. This defect could affect the intended function of the pressure relief mechanism in ventilator setups.
The affected products were distributed nationwide in the United States, including in Alabama, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Washington, and Wyoming. Healthcare facilities and consumers who have these specific catalog and lot numbers should stop using the devices and contact Teleflex for instructions on replacement or return.
The recalled product
- Product
- Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
- Manufacturer
- TELEFLEX-MORRISVILLE
- Hazard
- Affected units
- 9,312
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 (6)
- Catalog # 2691 SKU #: XTF0046 Lot #'s: 180806
- 180910
- 181029
- 181105
- 181204
- 190225 and 190327
Distribution
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