A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol. 1.0 mL, 2 Luer Activated Valves, Male Luer Lock Adapter, Single use only Product Usage: The IV extension tubing kits are intended to provide users with a ready to use set up for the administration and withdrawal of fluids avoiding the need to acquire/assemble components from various manufacturers. The IV extension tubing sets are indicated for use with a vascular access device for administration and withdrawal of fluids.
FDA Recall Z-1271-2013 · Posted 2013-05-07
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Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeFPA
Date Initiated2013-03-28
Date Terminated2017-07-31
Product QuantityA) Product Code 2N8371: 513,000 units
Reason for Recall
Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
Firm Action
Baxter sent an "Urgent Product Notification" dated March 28, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taked. Customers are advised to locate and remove all of the affected products from their inventory. If the products were further distributed, consigneees are requested to notify their customers of the recall. Products can be returned for credit by contacting Baxter. An acknowledgement form is required to be compelted by customers.
Root Cause
Packaging process control
Distribution Pattern
Worldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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