Sorin Group SMART Perfusion Pack Recall: Risk of Sterile Barrier Breach
Sorin Group recalls SMART Perfusion Packs with potential sterile barrier breaches due to small pinholes in packaging. Affected units include specific lot numbers.
Lower-risk 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.
Contact the company
What happened, in plain English
Sorin Group is recalling SMART Perfusion Packs that may have small pinholes in their packaging, risking a sterile barrier breach. This could lead to contamination of medical devices during use. Read more at govinfonow.com/recall/73494-sorin-group-smart-perfusion-pack-recall-risk-of-sterile-barrier.
Source Summary by GovInfoNow · govinfonow.com/recall/73494-sorin-group-smart-perfusion-pack-recall-risk-of-sterile-barrier · Updated September 21, 2026 · FDA enforcement record: FDA #Z-2795-2017
Cite this page
“Sorin Group SMART Perfusion Pack Recall: Risk of Sterile Barrier Breach.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73494-sorin-group-smart-perfusion-pack-recall-risk-of-sterile-barrier. Based on FDA recall #Z-2795-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2795-2017%22&limit=1).
Why it’s dangerous
The packaging may have pinholes (about 1mm or smaller) that could compromise the sterile barrier. This might allow contamination of the medical device during use, potentially leading to infections.
Who’s affected
Healthcare professionals using these packs for medical procedures are most at risk. Patients receiving treatments with the recalled packs could be affected.
How to tell if you have this one
Check for the product name 'SMART PERFUSION PACK, SMART 1/4" PEDS PACK' with lot numbers 1621400045 or 1628600043.
- Brand
Sorin Group- Category
Medical device
All 16 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2783-2017 | SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA; Lot Numbers: 1625200040, 1635400048, 1704700039, 1706700087, 1711400055, 1717200038 | 50 units |
| Z-2784-2017 | SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only, 1 EA; Lot Numbers: 1620000123, 1622800056, 1623500052m 1627700083, 1631200074, 1700300040, 1701000065, 1703700061, 1706500063, 1708000068, 1717000057 | 98 units |
| Z-2785-2017 | SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA; Lot Numbers: 1620700048, 1621600063, 1623700039, 1624500038, 1625900047, 1626500084, 1627800066, 1628500062, 1630000040, 1630500055, 1631400035, 1633300052, 1635400049, 1700600038, 1702500069, 1704500039, 1706600107, 1707400082, 1708600072, 1710800102, 1711700034, 1713600045, 1715000038, 1717000046 | 524 units |
| Z-2786-2017 | SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA; Lot Numbers: 1626400126, 1628100032, 1631900034, 1632800034, 1703300043, 1707400063, 1708000042, 1710000040, 1716500018 | 52 units |
| Z-2787-2017 | SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERILE EO, Rx Only, 1 EA; Lot numbers: 1620200038, 1621700037, 1622800048, 1623100036, 1623700036, 1625700047, 1627900048, 1630500054, 1630600077, 1631900048, 1632700043, 1633500024, 1701000056, 1701600055, 1701800042 1704500037, 1705300070, 1706100042, 1707600055, 1706600103, 1707900056, 1708900035, 1710700038, 1712400062, 1713600042, 1714400058, 1715200088, 1715800067 | 632 units |
| Z-2788-2017 | SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 AND (b) REF 044011200, STERILE EO, Rx Only, 1 EA; Lot Numbers: (a) 1703100033, 1703200057, 1705400037, 1707900050, 1708200042, 1710200084, 1713700057, 1715900028 (b) 1619500015, 1620300020, 1623000025, 1623700026, 1624400017, 1625100125, 1626500068, 1627900033, 1628600023, 1629400030, 1632800035, 1634200023, 1634900050, 1635600025, 1700300019, 1700500032, 1702300048, 1703200053, 1703900069 | 733 units |
| Z-2789-2017 | SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only, 1 EA; Lot Number 1703300074 | 5 units |
| Z-2790-2017 | SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STERILE EO, Rx Only, 1 EA; Lot Numbers: 1621400046, 1623100048, 1706100049, 1706500064 | 32 units |
| Z-2791-2017 | STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703, STERILE EO, Rx Only, 1 EA; Lot Number 1709500117 | 1 unit |
| Z-2792-2017 | SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx Only, 1 EA; Lot Numbers: 1620000113, 1622400049, 1624300090, 1631200072, 1632100059, 1632800059, 1633300054, 1705100057, 1711500053 | 54 units |
| Z-2793-2017 | SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA; Lot Numbers: 1622100055, 1625200039, 1629800049 | 8 units |
| Z-2794-2017 | SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA; Lot Number 1717300032 | 1 unit |
| Z-2795-2017 | SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA; Lot Numbers: 1621400045, 1628600043 | 4 units |
| Z-2796-2017 | NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLINICAL USE; Lot Number 1627300090 | 1 unit |
| Z-2797-2017 | NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 627366901, 1 EA, NOT FOR CLINICAL USE; Lot Number 1623100001 | 1 unit |
| Z-2798-2017 | NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE; Lot Number 1703700067 | 1 unit |
What to do — step by step
Check Product Lot Number
Look for lot numbers 1621400045 or 1628600043 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.8 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2795-2017 (June 29, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2795-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.