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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Device vented gas below the stated pressure."
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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