LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach
LivaNova is recalling Perfusion Tube Sets because included display sets may have packaging pinholes that compromise sterility.
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 potential sterile barrier breach in a medical device, which poses a risk of infection or harm, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
LivaNova is recalling Perfusion Tube Sets (PTS) because they include Medtronic DLP Pressure Disposable Display Sets packaged in pouches with potential small pinholes. These pinholes, approximately 1mm or less in diameter, may cause a sterile barrier breach in the display sets.
The affected display sets were distributed to customers as part of the LivaNova Perfusion Tube Sets. The recall is limited to Lot Number 1717300032 of the Sorin Group Smart Perfusion Pack, Inspire 8S, Ref 044036101, which is sterile and requires a prescription.
Healthcare providers and facilities should stop using the affected products and contact LivaNova or Medtronic for further instructions on returns or replacements. Patients who have received these products should consult their healthcare provider.
The recalled product
- Product
- SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA
- Manufacturer
- Sorin Group USA, Inc.
- Affected units
- 1
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 Number 1717300032
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 16 recalled by Sorin Group USA, Inc. 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.
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