Baxter CLEARLINK System Non-DEHP Three Lead Extension recall: Sterility Concern
Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL, Luer Activated Valve, male Luer Lock Adapter, Sterile, nonpyrogenic…
Why was Baxter CLEARLINK System Non-DEHP Three Lead Extension recalled?
The firm is issuing a voluntary recall due to the potential for pinholes in the packaging. Pinholes are a breach in the sterile barrier and could lead to potential contamination.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UR13C11089, UR13D16060
- Product
- Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL, Luer Activated Valve, male Luer Lock Adapter, Sterile, nonpyrogenic…
- Recalling firm
- Baxter Healthcare Corp.
- Quantity
- 3,200 units
- Distribution
- US Distribution including the states of OK, GA, CA, MN, TX and HI.
- Recall date
- November 6, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)