Z-1343-2018Class II

6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave Clear, NanoClave T-Connector, 4 Clamps, Rotating...

Name: Z-1343-2018 6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave Clear, NanoClave T-Connector, 4 Clamps, Rotating...
Creator: ICU Medical, Inc.
Published: 2018-02-05
License: https://open.fda.gov/license/

Abbott Medical / initiated 2018-02-05 / Terminated / root cause: manufacturing process

FDA source

ICU Medical, Inc. began a recall of 6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave Clear, NanoClave T-Connector, 4 Clamps, Rotating Luer, Item A1254, 50 pouches per case, Sterile, Rx... on 2018-02-05. FDA classified it as Class II and gives the reason as "The infusion sets were manufactured with an incorrect spin collar". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1343-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-05
Posted: 2018-04-10
Terminated: 2019-09-17
Recalling firm: Abbott Medical
Product: 6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave Clear, NanoClave T-Connector, 4 Clamps, Rotating Luer, Item A1254, 50 pouches per case, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
Product code: FMG Stopcock, I.V. Set
Reason for recall: The infusion sets were manufactured with an incorrect spin collar.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, ICU Medical Inc., sent an "URGENT: Medical Device Recall Notification" letter dated 2/5/2018 to its customers via UPS on 2/5/2018 in the U.S. The letter described the product, problem and actions to be taken. The customers were instructed to: inspect your inventory for specific product and lot numbers; quarantine all affected devices; complete and return the Recall Response Form as applicable (even if you have no affected devices) via Fax to: 1-866-899-7474 or email to: [email protected]; if you have distributed the product further, notify your accounts that received the product and ask them to contact Stericycle at 1-866-629-6182 (M-F, 8am-5pm ET) to receive a Response Form. Return affected product to Stericycle using labels provided, if you have not received a return label or reply form or require additional assistance, please contact Stericycle at 1-866-629-6182 (M-F, 8am-5pm) the return labels are for single use only. For additional labels visit http://expertezlabel.com. For further inquiries, please contact ICU Medical Inc. for Global Complaint Management at [email protected] or ICU Customer Service at 1-866-829-9025, option 2 (M-F, 8:30am-4pm PT).
Quantity in commerce: 550 pouches
Distribution: Worldwide Distribution: US (nationwide) to state in AZ, CA, CO, FL, SC, and TX; and countries of: Canada and Japan.
Product codes and lots: Lot number 3533699, UDI (01) 0 0887709 09040 8 (17) 220901 (30) 01 (10) 3533699, and lot number 3549590, UDI (01) 0 0887709 09040 8 (17) 221001 (30) 01 (10) 3549590.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1343-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1342-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-10
Z-1343-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-10
Z-1344-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-10
Z-1345-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-10
Z-1346-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-10
Z-1347-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-10

Product code FMG

K964435Class IIPrimary IV SetIcu Medical, Inc. / cleared 1997-04-02

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)