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Terminated

A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter, Single use only; B) Product Code 2N1206: Non-DEHP I.V. Catheter Extension Set, 5.7", Vol. 0.7 mL, Male Luer Lock Adapter with Retractable Collar, Single use only Product Usage: These devices are indicated for use with a vascular access device for administration and withdrawal of fluids.

FDA Recall Z-1268-2013 · Posted 2013-05-07

Recall StatusTerminated
Product CodeFPA
Date Initiated2013-03-28
Date Terminated2017-07-31
Product QuantityA) Product Code 2N1191: 53,850; B) Product Code 2N1206: 101,900 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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