—#157942

Product

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

FDA product code: DWE — Tubing, Pump, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K981613
Affected lot / code info: 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

Why it was 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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Sorin Group USA, Inc.
Address: 14401 W 65th Way, Arvada, Colorado 80004-3503

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2017-06-29
Terminated: 2021-04-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #157942. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.