Baxter Healthcare Corp. Rt Fenwal Y-Type Blood Component Recipient Set with Standard Blood Filter, 10 drops/mL, 65'', 170 to 260 Micron Filter, catalog 4C2196; Baxter Healthcare Corporation, Deerfield, IL 60015 USA Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Fenwal Y-Type Blood Component Recipient Set with Standard Blood Filter, 10 drops/mL, 65'', 170 to 260 Micron Filter, catalog 4C2196; Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Brand
Baxter Healthcare Corp. Rt
Lot Codes / Batch Numbers
catalog 4C2196
Products Sold
catalog 4C2196, lot numbers UR117606 through UR122614. Please note: Baxter lot numbers are represented by an internal reference code ''UR'' followed by a six digit sequential number, or by the letter ''U'' followed by a six digit sequential number with and ''R'' suffix. Any lot number appearing within the identified six digit sequential number range is subject to the recall.
Baxter Healthcare Corp. Rt is recalling Fenwal Y-Type Blood Component Recipient Set with Standard Blood Filter, 10 drops/mL, 65'', 170 to 26 due to There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
Recommended Action
Per FDA guidance
Recalled by letter dated 7/16/03. The accounts were informed of the potential for leaks in the set tubing, and asked to inspect their inventory for the affected product codes and lots, segregate any affected products found and discard them according to local procedures. The customers will receive credit for the discarded affected product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026