Z-2662-2018Class II

Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism

Name: Z-2662-2018 Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism
Creator: Smiths Medical ASD Inc.
Published: 2018-04-13
License: https://open.fda.gov/license/

Abbott Medical / initiated 2018-04-13 / Terminated

FDA source

Smiths Medical ASD Inc. began a recall of Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism on 2018-04-13. FDA classified it as Class II and gives the reason as "Certain Barrel Clamp Guides may contain a ridge that could potentially lead to spring slippage, resulting in the inability of the pump to recognize a loaded syringe or the pump, misidentifying the size of a loaded...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2662-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-13
Posted: 2018-08-08
Terminated: 2023-01-30
Recalling firm: Abbott Medical
Product: Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism
Product code: FRN Pump, Infusion
Reason for recall: Certain Barrel Clamp Guides may contain a ridge that could potentially lead to spring slippage, resulting in the inability of the pump to recognize a loaded syringe or the pump, misidentifying the size of a loaded syringe.
FDA root cause: Process change control
Action: Customers were notified of the recall on about 04/13/2018 via URGENT MEDICAL DEVICE RECALL NOTICE letter. Instructions included to evaluate current inventory for affected Barrel Clamp Guide, review and complete the Recall Response Form, return affected Barrel Clamp Guides to Stericycle for destruction, and if the affected Barrel Clamp Guides have already been installed in pumps, continue to use the pumps, but utilize the Syringe Verification Reference Tool provided with the Recall Notice until the pumps are repaired. Customers were also instructed to notify customers if the affected devices were further distributed. Questions regarding the recall can be directed to Stericycle at [email protected].
Quantity in commerce: 276 units
Distribution: US distribution to AL, AZ, CA, DC, FL, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NJ, NM, NY, OH, OK, PA, TN, TX, UT, VA, WA. International distribution to Canada and Lebanon.
Product codes and lots: Barrel Clamp Guide mechanism number: G6000716; Barrel Clamp Guide lot numbers: P0239588, P0321444, and P0462421

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2662-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2662-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-15	2018-08-08

Product code FRN

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)