Baxter Interlink System Y-Type Minivolume Extension Set… recallZ-1102-05 · Baxter Healthcare Corp. · initiated Jul 6, 2005
Terminated All recalls posted in August 2005
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Leaks and disconnection between the bifurcated Y-site and the set tubing may occur and result in underdelivery of medication, blood loss, and a breach of the sterile fluid pathway.
FDA root cause category: Other
What the company is doing
Baxter sent Urgent Product Recall letters dated 7/6/05 to their customers, to the attention of the Director of Materials Management, via first class mail on the same date. The accounts were informed of the complaints of leaks and disconnection between the bifurcated Y-site and the set tubing, resulting in the possible under delivery of medication, blood loss and a breach of the sterile fluid pathway. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and return it to Baxter for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837.
Recall details
- Recall number
- Z-1102-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 6, 2005
- Posted by the FDA
- Aug 6, 2005
- Recalling firm
- Baxter Healthcare Corp.
- Quantity
- 8,256 sets
- Product code
- FPA
- FDA submissions
- K925126
- Distribution
- Arizona, Georgia, Illinois, Michigan, Ohio, Pennsylvania, South Carolina and Texas.
Product description
Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8645; 9'', 0.8 mL Vol., with 2 injection sites and a male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
Code information (models, lots, serial numbers)
product code 1C8645, lots GR222042, GR224667, GR227173, GR228114;
Other devices under the same FDA submission
4 devices cleared under K925126 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- INTERLINK 2N3374Baxter International Inc. · Set, administration, intravascular7 reports
- INTERLINK 2N3378Baxter International Inc. · Set, administration, intravascular7 reports
- INTERLINK 2N3379Baxter Healthcare Corporation · Set, administration, intravascular6 reports
- INTERLINK 2N3399Baxter Healthcare Corporation · Set, administration, intravascular2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 32588).
- Z-1099-05 · TerminatedBaxter Interlink System Minivolume Extension Set, product code 1C8290; 11'', 0.86 mL Vol., with 2 injection sites and a male Luer Lock adapter; Baxter Healthcare Corporation, Deerf…
- Z-1103-05 · TerminatedBaxter Interlink System Y-Type Minivolume Extension Set, product code 1C8689; 6'', 0.33 mL Vol., with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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