FDA Medical Device Recalls (openFDA)
Vital Signs Inc: Vital Signs Inc. enFlow Disposable IV Fluid/Blood Warmer Cartridge. Medical point-of-care device designed to warm blood and IV fluids.
- Recall number
- Z-2380-2010
- 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.
- Status
- Terminated
- Initiated
- 2010-07-15
- Posted
- 2010-09-03
- Terminated
- 2015-04-27
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K060537"]
- PMA numbers
- not on file
- Product code
- LGZ
- Firm FEI
- 2242551
- Firm city
- Totowa
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28