Product Safety Recalls

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ICU Medical, Inc. Recall 90726

Description: 8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;

ICU Medical, Inc. Recall 90726 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1720-2022
Event ID90726
Event Description8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;
Product TypeDevices
DistributionU.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.
QuantityTotal of all affected units = 5,795,989 units
Recall ReasonDue to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
Device Classification20220921
Device Code InfoProduct Number: 12517-01 UDI Code: 0110887709047201172612013050105735675 0110887709047201172612013050105755784 0110887709047201172612013050105755788 0110887709047201172702013050105812525 Lot Numbers: 5735675 5755784 5755788 5812525 Product Number: A1099 UDI Codes: 0110887709053127172611013050105692378 Lot Numbers: 5692378 Product Number: A1129 UDI Code: 0110887709068190172612013050105755485 0110887709068190172701013050105772087 Lot Number 5755485 5772087 Product Number: A1132 UDI Code: 0110887709068350172701013050105772482 Lot Number: 5772482 Product Number: A1152 UDI Code: 0110887709071527172612013050105735432 0110887709071527172701013050105787700 Lot Number: 5735432 5787700 Product Number: MC330113 UDI Codes: 0110887709078120172612013050105746371 0110887709078120172612013050105755711 0110887709078120172701013050105789359 Lot Numbers: 5746371 5755711 5789359 Product Number: MC330246 UDI Codes: 0110887709081502172610013050105641882 0110887709081502172612013050105738474 0110887709081502172701013050105773798 0110887709081502172701013050105788509 0110887709081502172701013050105809713 Lot Numbers: 5641882 5738474 5773798 5788509 5809713 Product Number: MC330247 UDI Codes: 0110887709081519172612013050105745619 0110887709081519172612013050105756766 0110887709081519172701013050105777168 0110887709081519172701013050105789411 Lot Numbers: 5745619 5756766 5777168 5789411 Product Number: MC33056 UDI Code: 0110887709037301172701013050105772683 Lot Number: 5772683 Product Number: MC330605 UDI Code: 0110887709097008172701013050105789539 Lot Number: 5789539 Product Number: MC33122 UDI Codes: 0110887709037400172612013050105757061 0110887709037400172701013050105772640 0110887709037400172701013050105788745 Lot Numbers: 5757061 5772640 5788745 Product Number: MC33213 UDI Codes: 0110887709037516172612013050105736601 0110887709037516172701013050105789780 0110887709037516172701013050105789784 Lot Numbers: 5736601 5789780 5789784 Product Number: MC33326 UDI Codes: 0110887709037752172612013050105757376 0110887709037752172701013050105772627 0110887709037752172701013050105772638 0110887709037752172702013050105810377 Lot Numbers: 5757376 5772627 5772638 5810377 Product Number: MC33600 UDI Code: 0110887709051932172701013050105789950 Lot Number: 5789950 Product Number: MC33729 UDI Codes: 0110887709065045172701013050105789984 0110887709065045172701013050105800993 Lot Numbers: 5789984 5800993 Product Number: MC33786 UDI Code: 0110887709067551172701013050105778247 Lot Number: 5778247 Product Number: Z3419 UDI Code: 0110887709032108172612013050105754551 Lot Number: 5754551 Product Number: Z3678 UDI Codes: 0110887709034607172612013050105754702 0110887709034607172701013050105777801 Lot Numbers: 5754702 5777801
Center Classification Date20220909
Recall Initiation Date20220801
Recalling FirmICU Medical, Inc.
Initial Notification Letter
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