Reported Aug 9, 2017 · Terminated
SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA
Sorin Group USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sorin Group USA, Inc. · 14401 W 65th Way · Arvada, CO · 80004-3503
Is this the product you have?
- SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA
- Lot codes and dates
- Lot Numbers
162070004816216000631623700039162450003816259000471626500084162780006616285000621630000040163050005516314000351633300052163540004917006000381702500069170450003917066001071707400082170860007217108001021711700034171360004517150000381717000046
- Lot Numbers
- Amount recalled
- 524 units
This recall covers 16 products
The agency filed one notice per product. You are reading one of them; the other 15 are below.
3 more are in the archive.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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