Skip to content

Baxter ClearLink Intravenous (IV) Solution Sets and… recallZ-0845-05 · Baxter Healthcare Corp. · initiated Feb 28, 2005

Terminated All recalls posted in May 2005

Is my device affected?

  1. 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.
  2. 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.
  3. 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

Possible occlusion of the Clearlink injection site valve due to inadequate silicone lubrication of the slit in the upper seal of the valve.

FDA root cause category: Other

What the company is doing

Recall letters dated 2/28/05 were sent to the direct accounts via first class mail on the same date to the attention of the Director of Nursing. The accounts were informed of the increase in reports of ClearLink valve occlusion, requested to examine their inventory for the affected lots of product, and call Baxter Healthcare Center for Service at 1-888-229-001 to return the affected product for credit. The letters included a copy of the Technical Letter revised 5/4/04, outlining the correct preparation and use ClearLink valve product, including detecting valve re-knits.

Recall details

Recall number
Z-0845-05
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Feb 28, 2005
Posted by the FDA
May 17, 2005
Recalling firm
Baxter Healthcare Corp.
Quantity
1,171,116 sets
Product code
FPA
FDA submissions
K003225, K791496, K961225, K962581, K984381
Distribution
Nationwide, including Puerto Rico and American Samoa, and internationally to Canada, Panama, Australia, New Zealand and Venezuela.

Product description

Baxter ClearLink Intravenous (IV) Solution Sets and Extension Sets that have a ClearLink luer activated valve for IV access, which allows the administration of medications/solutions with a needleless luer syringe; Baxter Healthcare Corporation, Deerfield, IL 60015 USA

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

Product code 2C6255, lot R04J12126;  Product code 2C8428, lot R04J11318; Product code 2C8515, lot R04J12043; Product code 2C8519, lots R04J12076, R04J12159;  Product code 2C8537, lots R04J11128, R04J11201, R04J12027, R04J12084, R04J12183, R04J13033, R04J13116, R04J13173, R04J14031, R04J14098, R04J14130, R04J14155, R04J15061; Product code 2C8546, lot R04J11177;  Product code 2C8571, lot R04J14205;  Product code 2C8606, lot R04J13025;  Product code 2C8612, lot R04J12019;  Product code 2C8632, lot R04J12258;  Product code 2C8634, lot R04J13090;  Product code 2C8819, lots UR241323, UR242560, UR242669; Product code 2C8864, lot UR240697; Product code 2C8865, lots UR241638, UR241786, UR244012;   Product code A2C9801, lots UR244020, UR245647;  Product code 2H8401, lot R04J12068;  Product code 2H8519, lots R04J15053, R04J16010;   Product code 2N8371, lot UR245027;  Product code 2N8373, lot UR243501;  Product code 2N8374, lots UR229138, UR229526, UR230193, UR230193X, UR230433, UR230458, UR240747, UR241059, UR241356, UR241505, UR242065, UR246033;  Product code 2N8378, lots UR229344, UR229781, UR230060, UR241133, UR241661, UR242107, UR242131, UR242362, UR242644, UR244632;  Product code 2N8399, lots UR230128, UR230573, UR231027, UR231704, UR239301, UR239889, UR240200, UR240945, UR241265, UR242081, UR242230, UR243576;

Other devices under the same FDA submission

25 devices cleared under K003225, K791496, K961225, K962581, K984381 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page