International Biophysics Recalls IBC Suction Wands Due to Seal Defects
International Biophysics Corp. is recalling 100 IBC Suction Wands because heat seals on sterile pouches may not meet strength criteria.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential failure of sterile packaging integrity without reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
International Biophysics Corp. is recalling 100 units of the IBC Suction Wand, Catalog Number 1990S. This product is a disposable, single-use component of a Blood Recovery System used in open heart procedures, autologous blood recovery, and blood suction.
The recall was initiated because it was discovered that the heat seal placed onto the sterile pouches may not meet strength acceptance criteria. The affected units were distributed worldwide, including the United States, Germany, Norway, Turkey, Chile, Pakistan, and the Republic of South Africa.
The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled units.
The recalled product
- Product
- IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component of Blood Recovery System for use in open heart procedures, autologous blood recovery and blood suction. It is a disposable, single use component.
- Manufacturer
- International Biophysics Corp.
- Affected units
- 100
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)
- 033115-3445
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by International Biophysics Corp. 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.
See all 3 products in this recall →Related recalls
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