Reported Apr 18, 2018 · Terminated
7" Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B9900-629,…
ICU Medical, 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: ICU Medical, Inc. · 951 Calle Amanecer · San Clemente, CA · 92673-6212
Is this the product you have?
- 7" Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B9900-629, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 Lot number 3482848, UDI (01) 0 0887709 01806 8 (17) 220701 (30) 01 (10) 3482848 2 lot number 3511823, UDI (01) 0 0887709 01806 8 (17) 220801 (30) 01 (10) 3511823 3 lot number 3516092, UDI (01) 0 0887709 01806 8 (17) 220801 (30) 01 (10) 3516092 4 and lot number 3545075, UDI (01) 0 0887709 01806 8 (17) 221001 (30) 01 (10) 3545075. - Amount recalled
- 2,950 pouches
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
The infusion sets were manufactured with an incorrect spin collar.
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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