FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: Baxter Interlink System, Micro-Infusion Manifold; and Interlink Manifold. An Rx sterile device with 3 injection sites, volume per injection site 0.1 mL, priming volume 0.8 mL, length 8.7 cm. Product code 2N3410 and A2N3410 - Japan Baxter Healthcare corporation, Deerfield, IL 60015 USA; Intended for use with a vascular access device for blood sampling and the administration of multiple drugs and solutions.
- Recall number
- Z-0502-2011
- Recalling firm
- Baxter Healthcare Corp.
- Product
- Baxter Interlink System, Micro-Infusion Manifold; and Interlink Manifold. An Rx sterile device with 3 injection sites, volume per injection site 0.1 mL, priming volume 0.8 mL, length 8.7 cm. Product code 2N3410 and A2N3410 - Japan Baxter Healthcare corporation, Deerfield, IL 60015 USA; Intended for use with a vascular access device for blood sampling and the administration of multiple drugs and solutions.
- Status
- Terminated
- Initiated
- 2010-10-21
- Posted
- 2010-12-01
- Terminated
- 2011-10-16
- Reason
- If the manifolds are connected in series, there may be a risk of the manifolds loosening or disconnecting at the luer connection between them.
- Root cause
- Other
- Action
- Baxter sent an "Urgent Device Correction" letter dated October 20, 2010, via first class mail to the direct accounts, to the attention of the Director of Nursing and the Director of Materials Management, informing them that there may be a risk of the manifolds loosening or disconnecting at the luer connection between them. The loosening or disconnection can result in an interruption of therapy, potentially resulting in patient injury and death. The accounts were requested to place the notification where the inventory of affected product is dispensed, so that users are made aware of the procedures to follow: "If these devices are connected in series, and the luer connector is tightened, do not twist the manifolds. This may lead to loosening or disconnection, which may cause a leak. Additionally, Baxter recommends checking all connections before starting and during infusion therapy." The accounts were requested to complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter at the number provided on the form. Dealers, wholesalers and distributors were requested to notify their customers of this action so they can comply with the procedures listed above. Any questions regarding the communication were directed to The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.
- Quantity
- 752,965 units in US and all lots in Japan
- Distribution
- Worldwide Distribution -- United States and Japan.
- Lot, serial or model codes
- product code 2N3410 and A2N3410 , all lots
- 510(k) numbers
- ["K970438"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 1416980
- Firm city
- Round Lake
- 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