FDA Devices Verify with FDA Devices → Moderate Class II Ongoing

Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY SPIKE/CL-12; APPX 1.5ml,ChemoLock BAG SPIKE WITH ADDITIVE PORT/CL-13; ChemoLock Port/CL2100; ChemoLock Port, 5 Units/CL2100-5; ChemoLock Port/CL2100T; Clave Bag Spike w ChemoLock Port/CL2150; 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger/CL3011; 9 IN(23cm)APPX 2.7ml,EXT SET,ChemoLock PORT,2 CLAMPS,2 GRADUATED CONN/

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on September 14, 2022. Severity: Moderate. Recall number: Z-1681-2022.

Q: Where was the recalled product distributed?

Distribution: Worldwide distribution - US Nationwide distribution including in the states of LA, FL, TX, NY, NE, WI, PA, IA, ND, CA, OH, WA, GA, AL, CO, AZ, NC, TN, MI, VA, MA, DE, OR, KY, CT, OK, NJ, MN, IL, VT, AR, RI, ID, IN, UT, NV, MT, MD, KS, SC, NM, ME, MO, SD and the countries of : Saudi Arabia, Australia, United Arab Emirates, Spain, Slovenia, Japan, Canada..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-1681-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Reviewed byPlainRecalls Editorial, Product Recalls Editorial Team · June 6, 2026

Reported: September 14, 2022 Initiated: June 27, 2022 #Z-1681-2022 454,635 units

ICU Medical, Inc. issued this FDA Devices recall on September 14, 2022. Classified as Moderate severity (Class II). Approximately 454,635 units are affected. The recall was issued because: Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a v…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

This FDA Devices action (record #Z-1681-2022) was formally reported on September 14, 2022, with the manufacturer initiating the action on June 27, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. ICU Medical, Inc. is listed as the recalling firm, operating out of San Clemente, CA. Federal records indicate 454,635 units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic sub… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution including in the states of LA, FL, TX, NY, NE, WI, PA, IA, ND, CA, OH, WA, GA, AL, CO, AZ, NC, TN, MI, VA, MA, DE, OR, KY, CT, OK, NJ, MN, IL, VT, AR, RI, ID, IN, UT, …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 4 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity

Moderate

Units Affected

454,635

Related Recalls

6 from same agency

Product Description

Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY SPIKE/CL-12; APPX 1.5ml,ChemoLock BAG SPIKE WITH ADDITIVE PORT/CL-13; ChemoLock Port/CL2100; ChemoLock Port, 5 Units/CL2100-5; ChemoLock Port/CL2100T; Clave Bag Spike w ChemoLock Port/CL2150; 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger/CL3011; 9 IN(23cm)APPX 2.7ml,EXT SET,ChemoLock PORT,2 CLAMPS,2 GRADUATED CONN/CL3364; Syringe Transfer Set w Clave, ChemoLock Port/CL-34; 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w Integrated ChemoLock Port Drip Chamber, ChemoLock w Red Cap, Bag Hanger/CL3511; 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w Integrated ChemoLock Port Drip Chamber, ChemoLock w Red Cap, Bag Hanger/CL3511T; 30" (76cm) Appx 6.3 ml, 20 Drop Admin Set w Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter, ChemoLock w Red Cap, Hanger/CL3528; 7" (18 cm) Appx .93 ml, Ext Set w/ChemoLock, Y-Connector, Rotating Luer/CL3535T; Oncology Kit w/5" (13 cm) Add-On Set w ChemoLock Additive Port, Vented Cap, ChemoLock, Spinning Spiros w Red Cap/CL3538; Graduated Connector w ChemoLock Port/CL3900; ONCOLOGY KIT, EXT,ChemoLock PORT, GRAD CONN,TRANSFER,ChemoLock,VIAL SPIKE,ChemoLock PORT/CL3927; Oncology Kit w 5" (13 cm) Add-On Set w ChemoLock w Red Cap, Vented Cap, ChemoLock Port w Bag Spike, Spiros w Red Cap/CL3946; Oncology Kit w 17" (43 cm) Bifuse Ext Set w/ChemoLock w Red Cap, ChemoLock Port, ChemoLock Vented Vial Spike, 13mm ChemoLock/CL3947; Oncology Kit w ChemoLock Port Closed Vial Spike, ChemoLock, ChemoLock Port Bag Spike/CL3952; APPX 0.5ml, ChemoLock BAG SPIKE WITH ADDITIVE PORT,ChemoLock Port/CL3955;

Reason for Recall

Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports available as standalone connectors, or utilized as access points on vial adaptors, bag spikes, and administration sets.

Details

Recalling Firm: ICU Medical, Inc.
Units Affected: 454,635
Distribution: Worldwide distribution - US Nationwide distribution including in the states of LA, FL, TX, NY, NE, WI, PA, IA, ND, CA, OH, WA, GA, AL, CO, AZ, NC, TN, MI, VA, MA, DE, OR, KY, CT, OK, NJ, MN, IL, VT, AR, RI, ID, IN, UT, NV, MT, MD, KS, SC, NM, ME, MO, SD and the countries of : Saudi Arabia, Australia, United Arab Emirates, Spain, Slovenia, Japan, Canada.
Location: San Clemente, CA

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Ongoing
Recall number	Z-1681-2022
Date reported	September 14, 2022
Date initiated	June 27, 2022
Recalling firm	ICU Medical, Inc.
Units affected	454,635
Distribution	Worldwide distribution - US Nationwide distribution including in the states of LA, FL, TX, NY, NE, WI, PA, IA, ND, CA, OH, WA, GA, AL, CO, AZ, NC, TN, MI, VA, MA, DE, OR, KY, CT, OK, NJ, MN, IL, VT, AR, RI, ID, IN, UT, NV, MT, MD, KS, SC, …

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

454,635 units affected — multi-state distribution scale.

Regional (<10K units) —

Multi-state (10K – 100K units) —

Large-scale (100K – 1M units) ✓ This recall

Massive (≥1M units) —

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on September 14, 2022. Severity: Moderate. Recall number: Z-1681-2022.

Where was the recalled product distributed? ▼

Distribution: Worldwide distribution - US Nationwide distribution including in the states of LA, FL, TX, NY, NE, WI, PA, IA, ND, CA, OH, WA, GA, AL, CO, AZ, NC, TN, MI, VA, MA, DE, OR, KY, CT, OK, NJ, MN, IL, VT, AR, RI, ID, IN, UT, NV, MT, MD, KS, SC, NM, ME, MO, SD and the countries of : Saudi Arabia, Australia, United Arab Emirates, Spain, Slovenia, Japan, Canada..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-1681-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Recall Guides

Learn how the US recall system works and how to protect yourself and your household.

How the US Recall System Works

The three federal agencies, how recalls are initiated, and what happens next.

Understanding Recall Severity Classes

What Class I, II, and III mean and which recalls demand immediate action.

What to Do When a Product Is Recalled

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How to Check If Your Products Are Recalled

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Recalled Products in Your Home

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Most Recalled Product Categories

Rankings of highest-recall categories from FDA, CPSC, and NHTSA.

Recall Context

Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

Related Safety Data

Explore related product safety and public health data from federal sources.

Food Safety Inspections

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PlainFoodSafe →

Ingredient Safety Data

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USDA nutrition facts for 2M+ food items — calories, macros, vitamins, and ingredient analysis to verify what you consume.

GetFoodFacts →

Drug Safety Information

FDA drug data for 680+ medications — interactions, alternatives, side effects, and safety information for recalled and active drugs.

PlainMeds →

Product Injury Data

CPSC emergency room injury data for 838 product categories — 7.3M NEISS records tracking real-world consumer product injuries.

PlainSafety →

Recall Checker

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Live feed of the latest recalls across FDA, CPSC, NHTSA, and USDA — filter by agency and severity.

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Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

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Compare this recall with Endo-Model Replacement Plateau; Item Number: 15-0027/11; →

Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Read our methodology — how this data is sourced, computed, and verified.

All federal data sources used on this page

U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Accessed 2026-06-06 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).