8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotat
Summary
The FDA issued a Class II for 8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv 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-1720-2022
Action Date
2022-09-21
Status
Ongoing
Category
device
Product 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;
Lot/Code Info: Product 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
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-1720-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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