Reported Sep 21, 2022 · Ongoing
MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed…
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?
- MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed in the vein or artery.
- Lot codes and dates
5 of 5 products
Products covered by this recall Model / number Product as published 12512-01Lot Numbers: 5716986 5716988 5716989 5716990 5716992 5716993 5716994 5737649 5737651 5739477 5739478 5739482 5739484 5739493 5755652 5757425 5757426 5771936 5771950 5771956 5786565 5815050 UDI Codes: 01108877090505391726120130100105724458 01108877090505391726120130100105736445 01108877090505391726120130100105739485 01108877090505391726120130100105739486 01108877090505391726120130100105739487 01108877090505391726120130100105739488 01108877090505391726120130100105754899 01108877090505391727010130100105771934 01108877090505391727010130100105793264 01108877090505391727010130100105798239 01108877090505391727010130100105802842 01108877090505391727020130100105812522 MC100-PRLot Numbers: 5724458 5736445 5739485 5739486 5739487 5739488 5754899 5771934 5793264 5798239 5802842 5812522 UDI Code: 01108877090372021726120130100105738352 MC330446Lot Number 5738352 UDI Code: 0110887709089096172612013050105746457 MC330545Lot Number: 5746457 UDI Code: 0110887709093222172701013050105773182 — Lot Number: 5773182 - Amount recalled
- Total of all affected units = 5,795,989 units
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
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
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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