Reported Jan 18, 2017 · Terminated
Tego Connector, Item No. D1000, NM1000 The Tego¿ Needle Free Access Device is intended for use as an accessory to a…
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?
- Tego Connector, Item No. D1000, NM1000 The Tego¿ Needle Free Access Device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an Intravascular Administration Set for the administration or withdrawal of fluids to a patient through a cannula or needle placed in the vein or artery. The Tego¿ is a needle-free capping device which closes the end of the catheter. The Tego¿ will permit access to the catheter without the use of needles and therefore passively aid in the reduction of needle stick injuries.
- Lot codes and dates
323984132398483244021324402232440233244558324456032461963254636325585032580043258326325832732606563261516326151732659753268523326959332695943275467327896632789673224799
- Amount recalled
- 476,600 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
ICU Medical Inc. has identified a potential risk of leaking with certain Tego Connector devices.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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