FDAFDA · Food and drugs·Recall number Z-1722-2022
MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral Connector, Approx Priming Volume: 0.04 mL. Accessory for Intravascular Administration Set
Published September 21, 2022 · Recall initiated: August 1, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ICU Medical, Inc.
- Distributor
- 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.
- Lot
- Product Number: 011-MC100 UDI Code: 01108406190425061726120130100105737404 01108406190425061726120130100105740700 01108406190425061726120130100105740701 01108406190425061726120130100105740702 01108406190425061726120130100105740703 01108406190425061726120130100105740705 01108406190425061726120130100105740706 01108406190425061726120130100105740707 01108406190425061726120130100105740708 01108406190425061726120130100105740712 01108406190425061726120130100105740713 01108406190425061726120130100105740714 01108406190425061726120130100105740715 01108406190425061726120130100105740719 01108406190425061726120130100105740721 01108406190425061727010130100105793254 01108406190425061727010130100105793255 01108406190425061727010130100105793259 Lot Numbers: 5737404 5740700 5740701 5740702 5740703 5740705 5740706 5740707 5740708 5740712 5740713 5740714 5740715 5740719 5740721 5793254 5793255 5793259 Product Number: MR4001 UDI Codes: 01108877090796081726120130100105738132 Lot Numbers: 5738132 Product Number: MS984 UDI Code: 01108424721008291726120130100105737492 Lot Number 5737492 Product Number: SC3000 UDI Code: 01108877090818301726120130100105726857 01108877090818301726120130100105753967 Lot Number: 5726857 5753967
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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