Z-0709-2021Class II

Spinning Spiros Closed Male Luer, Red Cap, REF: IB-CH2000SC; 5" (13 cm) Appx 1.5 ml, Add-On Set w/Spiros...

Name: Z-0709-2021 Spinning Spiros Closed Male Luer, Red Cap, REF: IB-CH2000SC; 5" (13 cm) Appx 1.5 ml, Add-On Set w/Spiros...
Creator: ICU Medical, Inc.
Published: 2020-08-31
License: https://open.fda.gov/license/

Abbott Medical / initiated 2020-08-31 / Open, Classified / root cause: manufacturing process

FDA source

ICU Medical, Inc. began a recall of Spinning Spiros Closed Male Luer, Red Cap, REF: IB-CH2000SC; 5" (13 cm) Appx 1.5 ml, Add-On Set w/Spiros, REF: IB-CH3034; 5" (13 cm) Appx 1.5 ml, Bag Spike... on 2020-08-31. FDA classified it as Class II and gives the reason as "Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0709-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-08-31
Posted: 2020-12-23
Recalling firm: Abbott Medical
Product: Spinning Spiros Closed Male Luer, Red Cap, REF: IB-CH2000SC; 5" (13 cm) Appx 1.5 ml, Add-On Set w/Spiros, REF: IB-CH3034; 5" (13 cm) Appx 1.5 ml, Bag Spike Adapter w/Spiros, Vented Cap, REF: IB-CH3034C
Product code: FPA Set, Administration, Intravascular
Reason for recall: Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 08/31/2020, Medical Device Recall notices were mailed to customers informing them to take the following actions: 1) Please discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility. 2) Inform potential users of the product in your organization of this notification and complete the attached response form. Return the completed response form to the fax number or e-mail address on the form, even if you do not have the affected product. 3) ICU Medical has some lots of unaffected product available today and is actively increasing the amount of available inventory. In the event specific product is unavailable, consider use of the non-spinning Spiros or the ChemoLock CSTD as alternatives. Please contact customer service for product availability. 4) Return affected product using the return label provided with this letter. Contact Stericycle at 1-888-871-7108 (MF, 8am-5pm ET) if you have not received a return label or require additional labels for returning the affected product. 5) If you have distributed the product further, immediately notify your accounts that received the product identified in the Affected Product / Table 1 sections of this notification and ask them to contact Stericycle to obtain a response form. For further inquiries, please contact: Global Complaint Management, 1-844-654-7780 or [email protected]; Customer Service, 1-866-829-9025, option 8 or, [email protected], (M-F, 8am-6pm CT) On 10/07/2020, the Medical Device Recall notice, with an expanded affected device scope, was sent to customers.
Quantity in commerce: 37000
Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of FL, MD, LA, PA, IN, TX, NY, MO, VA, OH, GA, NC, IL, CA, AZ, AK, NE, DE, WI, CO, UT, ND, MS, MA, MN, WA, SC, OR, KS, MI, NH, NJ, KY, TN, ID, AR, CT, OK, AL, SD, ME, IA, VT, WY, DC, NV, RI, MT, NM, HI, WV and the countries of Italy, Belgium, United Kingdom, Canada, Germany, Argentina, Australia, Poland, Greece, Switzerland, Israel, France, Finland, Spain, Malaysia, Taiwan, Ireland, Luxembourg, Hong Kong , Brazil, Netherlands, Austria, Sweden, Turkey, Singapore, Slovakia, Croatia, South Africa, Romania, Thailand.
Product codes and lots: Lots: 4605119, 4726277, 4727007 ,

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0709-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0699-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0700-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0701-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0702-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0703-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0704-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0705-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0706-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0707-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0708-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0709-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0710-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0711-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-12-30	2020-12-23

Product code FPA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)