FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affiliate of Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. An IV transfer device, used to transfer fluids in pharmacy compounding system.
- Recall number
- Z-0109-2014
- Recalling firm
- Baxter Healthcare Corp.
- Product
- Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affiliate of Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. An IV transfer device, used to transfer fluids in pharmacy compounding system.
- Status
- Terminated
- Initiated
- 2013-08-30
- Posted
- 2013-10-30
- Terminated
- 2017-04-19
- Reason
- Potential tears in the pouch of six lots of Vented Spike Adapter Product Code 2C0471
- Root cause
- Packaging
- Action
- The firm, Baxter, sent an "Urgent Product Recall" letter dated September 10, 2013 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to locate and remove all affected product from your facility; If you distributed the products to other facilities or departments, forward them a copy of the letter; complete and return the attached Customer Reply Form via fax to 1-224-270-5457 or scan and email to fca@baxter.com; and contact Baxter Healthcare Center for Service at 1-888-229-0001 between hours of 7:00 am and 6:00pm Central Time to return affected product and receiving credit. For additional information contact the Center for One Baxter at 1-800-422-9837, Monday thru Friday during the hours of 8:00am to 5:00pm Central Time.
- Quantity
- 49,344 units
- Distribution
- Nationwide distribution.
- Lot, serial or model codes
- R13D09024, R13D09107, R13D12101, R13D17068, R13D18066, R13D20070
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- 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