FDA Medical Device Recalls (openFDA)
ConMed Corporation: STAT 2 Extension Set Gravity Flow Controller, 12 in. length, Catalog/REF No. S2-12, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- This is a disposable device with a sterile, nonpyrogenic fluid path. The STAT 2® Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body.
- Recall number
- Z-0630-2012
- Recalling firm
- ConMed Corporation
- Product
- STAT 2 Extension Set Gravity Flow Controller, 12 in. length, Catalog/REF No. S2-12, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- This is a disposable device with a sterile, nonpyrogenic fluid path. The STAT 2® Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body.
- Status
- Terminated
- Initiated
- 2011-04-15
- Posted
- 2012-01-11
- Terminated
- 2013-01-15
- Reason
- ConMed received complaints of some units exhibiting inaccurate or inconsistent flow rates. It was determined that certain units were assembled with an incorrect component which could result in the devices exhibiting a different flow rate and might reduce the ability of the user to regulate the device at low flow rates.
- Root cause
- Mixed-up of materials/components
- Action
- ConMed Corporation sent Urgent Medical Device Recall Letters and Response Forms dated April 14, 2011, via UPS Priority Mail pouches to all domestic consignees. The letter identified the product, the problem, and the action to be taken by the consignee. The international consignees were sent Urgent Medical Device Recall Letters and Response Forms dated April 22, 2011, via FedEx International Priority. Users were instructed to immediately stop use of the device and return it to ConMed Corporation. --- RECALL EXPANSION: Consignees were also instructed to contact all of those organization within their facility and any other facilities that they may have supplied or given these affected products to. ConMed Corp. sent out Amended Urgent Medical Device Recall Letters and Response Forms dated May 10, 2011, to the 4 consignees via UPS PriorIty Mail for the expansion of the recall for Catalog No. S2-12N, Lot 1006234. For any questions call 315-624-3237 or email ivcontroller@conmed.com.
- Quantity
- not on file
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Canada, Panama and India
- Lot, serial or model codes
- Beginning Lot Code 1006214, Ending Lot Code 1103304
- 510(k) numbers
- ["K964844"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 3001451571
- Firm city
- Utica
- Firm state
- NY
- 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