Z-2380-2010

Vital Signs Inc. enFlow Disposable IV Fluid/Blood Warmer Cartridge. Medical point-of-care device designed to...

Name: Z-2380-2010 Vital Signs Inc. enFlow Disposable IV Fluid/Blood Warmer Cartridge. Medical point-of-care device designed to...
Creator: Vital Signs Inc
Published: 2010-07-15
License: https://open.fda.gov/license/

Vital Signs, Inc. / initiated 2010-07-15 / Terminated / root cause: manufacturing process

FDA source

Vital Signs Inc began a recall of Vital Signs Inc. enFlow Disposable IV Fluid/Blood Warmer Cartridge. Medical point-of-care device designed to warm blood and IV fluids on 2010-07-15. The reason FDA records is "The enFlow Disposable IV Fluid/Blood Warmer Cartridge's male luer-lock fitting may be oversized and may not fit properly with standard female luer fittings". 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-2380-2010
Status: Terminated
Initiated: 2010-07-15
Posted: 2010-09-03
Terminated: 2015-04-27
Recalling firm: Vital Signs, Inc.
Product: Vital Signs Inc. enFlow Disposable IV Fluid/Blood Warmer Cartridge. Medical point-of-care device designed to warm blood and IV fluids.
Product code: LGZ Warmer, Thermal, Infusion Fluid
Reason for recall: The enFlow Disposable IV Fluid/Blood Warmer Cartridge's male luer-lock fitting may be oversized and may not fit properly with standard female luer fittings.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: GE Healthcare issued an "Urgent Medical Device Correction" letter, dated July 15, 2010, to consignees, identifying the reason for the recall and the affected lots. Customers were instructed to discontinue use of and quarantine the affected devices, and contact Vital Signs Inc. Customer Service to arrange for return and replacement of the affected devices. Consignees were instructed to complete and return the Confirmation Form. Consignees can contact Vital Signs Inc. Customer Service at 1-973-956-5300 .
Quantity in commerce: 385,820 domestic - 20,776 international
Distribution: Worldwide Distribution; USA (all states), and to the countries of Australia, Ecuador, Finland, India, Israel, Latvia, Lebanon, Malaysia, Mexico, Morocco, New Zealand, Panama, Philippines, Qatar, Saudi Arabia, Singapore, Switzerland, the Netherlands, and Vietnam.
Product codes and lots: Model numbers: 9800200, 9800202, 9800200EU, 9800202EU, 9100020010, 9100020210, 91000153, 91000154, 91000156. Master lot numbers on shipping cartons: oo1K through 365K, 001P through 365P, 001S through 365S. Shelf carton and unit level lot numbers" 0901xxxx through 1001xxxx

Product code LGZ

K060537Class IIEflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and Eflow Ac Power Supply, Model 120Enginivity, LLC / cleared 2006-06-08

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)