MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed i
Summary
The FDA issued a Class II for MicroClave Clear Neutral Connector. A bidirectional connector used as an accesso by ICU Medical, Inc.. Reason: Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing..
Details
Source
Device Recall
External ID
Z-1719-2022
Action Date
2022-09-21
Status
Ongoing
Category
device
Product Description
MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed in the vein or artery.
Lot/Code Info: Product Number: MC100 UDI Code: 01108877090371581726110130100105716986 01108877090371581726110130100105716988 01108877090371581726110130100105716989 01108877090371581726110130100105716990 01108877090371581726110130100105716992 01108877090371581726110130100105716993 01108877090371581726110130100105716994 01108877090371581726120130100105737649 01108877090371581726120130100105737651 01108877090371581726120130100105739477 01108877090371581726120130100105739478 01108877090371581726120130100105739482 01108877090371581726120130100105739484 01108877090371581726120130100105739493 01108877090371581726120130100105755652 01108877090371581726120130100105757425 01108877090371581726120130100105757426 01108877090371581727010130100105771936 01108877090371581727010130100105771950 01108877090371581727010130100105771956 01108877090371581727010130100105786565 01108877090371581727010130100105815050 Lot Numbers: 5716986 5716988 5716989 5716990 5716992 5716993 5716994 5737649 5737651 5739477 5739478 5739482 5739484 5739493 5755652 5757425 5757426 5771936 5771950 5771956 5786565 5815050 Product Number: 12512-01 UDI Codes: 01108877090505391726120130100105724458 01108877090505391726120130100105736445 01108877090505391726120130100105739485 01108877090505391726120130100105739486 01108877090505391726120130100105739487 01108877090505391726120130100105739488 01108877090505391726120130100105754899 01108877090505391727010130100105771934 01108877090505391727010130100105793264 01108877090505391727010130100105798239 01108877090505391727010130100105802842 01108877090505391727020130100105812522 Lot Numbers: 5724458 5736445 5739485 5739486 5739487 5739488 5754899 5771934 5793264 5798239 5802842 5812522 Product Number: MC100-PR UDI Code: 01108877090372021726120130100105738352 Lot Number 5738352 Product Number: MC330446 UDI Code: 0110887709089096172612013050105746457 Lot Number: 5746457 Product Number: MC330545 UDI Code: 0110887709093222172701013050105773182 Lot Number: 5773182
Quantity Affected: Total of all affected units = 5,795,989 units
Reason for Recall
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
Distribution
U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Austria, Bahrain, Belgium, Canada, Colombia, Estonia, France, Germany, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Peru, Poland, Saudi Arabia, Slovakia, Slovenia, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam. O.U.S.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-01
Company
San Clemente, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 161 device recalls issued in the same week, part of 413 device-related FDA actions this month.
ICU Medical, Inc. has 95 FDA actions in our database, including 85 recalls and 10 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ICU Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ICU Medical, Inc. have FDA actions?
ICU Medical, Inc. has 95 FDA actions in our database, including 85 recalls and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1719-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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