Baxter Clearlink System Non-DEHP 3 Port Adapter, 1.2 mL, 2… recallZ-0150-2011 · Baxter Healthcare Corp. · initiated Sep 9, 2010
Terminated All recalls posted in October 2010
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
During packaging testing, Baxter observed tears and pinholes in Chevron-style pouches for certain infusion disposable products. The pinholes and tears could compromise the sterile barrier properties of the pouch.
FDA root cause category: Package design/selection
What the company is doing
Baxter Healthcare Corporation sent an Urgent Product Recall letter dated September 9, 2010, to all customers. The letter identified the product, the problem and the action to be taken by the customer. The customers were requested to examine their inventory in all locations to determine if they had any of the affected lots of the affected product codes and to remove the affected product from their inventory; they were to call the Baxter Healthcare Center for Service at 1-888-229-0001 to return the affected product, request a credit, or request replacement product; 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 could 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.
Recall details
- Recall number
- Z-0150-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 9, 2010
- Posted by the FDA
- Oct 27, 2010
- Recalling firm
- Baxter Healthcare Corp.
- Quantity
- 108,000 sets
- Product code
- FPA
- FDA submissions
- K913627
- Distribution
- Worldwide Distribution - U.S., Canada, Japan, Australia, New Zealand, and Chile.
Product description
Baxter Clearlink System Non-DEHP 3 Port Adapter, 1.2 mL, 2 Luer Activated Valves for IV Access, Male Luer Lock Adapter; a sterile Rx device; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product 2N8334 For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
Code information (models, lots, serial numbers)
product 2N8334, lots UR214494, UR215400, UR232462, UR238121, UR269787, UR278440, UR283358, UR292524, UR299628, UR305292, UR312454, UR312611, UR322339, UR333070, UR345587, UR345876, UR355784, UR383984, UR07K21064, UR07K30149, UR07L07210, UR07L19173, UR08A10124, UR146118, UR158816, UR158881 and UR158915
Other devices under the same FDA submission
1 device cleared under K913627 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CLEARLINK 2N8334Baxter International Inc. · Set, administration, intravascular1 report
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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