Z-2785-2017Class II

SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA

Name: Z-2785-2017 SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA
Creator: Sorin Group USA, Inc.
Published: 2017-06-29
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2017-06-29 / Terminated / root cause: packaging

FDA source

Sorin Group USA, Inc. began a recall of SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA on 2017-06-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2785-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-29
Posted: 2017-07-29
Terminated: 2021-04-12
Recalling firm: LivaNova USA, Inc.
Product: SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA
Product code: DWE Tubing, Pump, Cardiopulmonary Bypass
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.
Root cause tag: packaging
FDA root cause: Other
Action: The firm initiated their recall verbally on 06/29/2017 and following with letters mailed on 07/13/2017. The actions to be taken by the customer: 1. Notify staff to not use the Medtronic labeled device contained within the LivaNova Perfusion Tube Set packs. 2. If the set is a standalone component within the pack, remove the device upon opening the pack at the time of the procedure. 3. If the device is connected to the circuit, remove the device and attach a new unit upon opening the pack. 4. Identify the Medtronic device with one of the barcode pack labels attached to the lidstock of the LivaNova perfusion pack. 5. Collect the devices for return to LivaNova until all affected perfusion sets have been consumed. In order to assist in controlling inventory, the LivaNova sales representative will have labels available to identify packs containing the affected devices. 6. Contact LivaNova Customer Support at (800) 650-2623 (M-F 8AM to 5PM MT) to arrange for the return of the affected product, and to order equivalent replacement product.
Quantity in commerce: 524 units
Distribution: Nationwide
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2785-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2783-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-09	2017-07-29
Z-2784-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-09	2017-07-29
Z-2785-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-09	2017-07-29
Z-2786-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-09	2017-07-29
Z-2787-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-09	2017-07-29
Z-2788-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-09	2017-07-29
Z-2789-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-09	2017-07-29
Z-2790-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-09	2017-07-29
Z-2791-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-09	2017-07-29
Z-2792-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-09	2017-07-29
Z-2793-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-09	2017-07-29
Z-2794-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-09	2017-07-29
Z-2795-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-09	2017-07-29
Z-2796-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-09	2017-07-29
Z-2797-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-09	2017-07-29
Z-2798-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-09	2017-07-29

Product code DWE

K981613Class IICobe Smarxt Tubing and ConnectorsCobe Cardiovascular, Inc. / cleared 1998-10-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)