CLASS II Device recall · Reported 9 Aug 2017 · FDA Enforcement Report
Sorin Group, Smart Perfusion Pack, Neonate/pediatric Pack recalled
Sorin Group USA is recalling Sorin Group, Smart Perfusion Pack, Neonate/pediatric Pack, distributed nationwide in the US. The recall was initiated on 29 Jun 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2792-2017
- FDA event ID
- 77810
- Recalling firm
- Sorin Group USA, Arvada, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jun 2017
- FDA classified
- 29 Jul 2017
- Reported
- 9 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 29 Jun 2017 | Recall initiated by company | |
| 29 Jul 2017 | Classified by FDA | +30 days |
| 9 Aug 2017 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx Only, 1 EA
Where it was distributed
Nationwide
Questions about this recall
Is Sorin Group, Smart Perfusion Pack, Neonate/pediatric Pack recalled?
Yes. Sorin Group USA recalled Sorin Group, Smart Perfusion Pack, Neonate/pediatric Pack on 29 Jun 2017. The recall is Class II and its status is Terminated. Recall number Z-2792-2017.
Why was it recalled?
Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.
Which lots are affected?
Lot Numbers: 1620000113, 1622400049, 1624300090, 1631200072, 1632100059, 1632800059, 1633300054, 1705100057, 1711500053
Where was it sold?
Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Sorin Group USA
All 52| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | FlexFlow Venous Cannula recalled by Sorin Group USA | Sorin Group USA | Sterility | Nationwide |
| Device | CLASS II | Sorin Group Aortic Arch Cannula x recalled | Sorin Group USA | Foreign Material | Nationwide |
| Device | CLASS II | Sorin Group, Smart Perfusion Pack, Smart Venous Vacuum recalled | Sorin Group USA | Sterility | Nationwide |
| Device | CLASS II | Sterile Sample Sorin Group, Smart Perfusion Pack recalled | Sorin Group USA | Sterility | Nationwide |
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