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Terminated

Baxter Interlink System Huber Needle Extension Set; a sterile 10'' fluid pathway with an Interlink Y-Injection Site and 3/4'' x 22 gauge needle; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.; product code 2N3709

FDA Recall Z-1048-05 · Posted 2005-07-28

Recall StatusTerminated
Product CodeFPA
Date Initiated2005-05-31
Date Terminated2006-05-23
Product Quantity4,850 sets

Reason for Recall

Some of the product code 2N3709 extension sets with Y-injections sites were placed in packages labeled as product code 2N3703 extension sets which do not have Y-injection sites.

Firm Action

Baxter sent Urgent Product Recall dated 5/31/05 to their customers on the same date, to the attention of the Director of Materials Management. The accounts were informed of the potential mislabeling, and were requested to check their inventory of any product code labeled 2N3703 or 2N3709 with lot number FC04058. If any of the affected lot is found the accounts were instructed to call Baxter Healthcare Center for Service at 1-888-229-0001 to arrrange for product return and replacement. Any questions were referred to the Center for One Baxter at 1-800-422-9837.

Root Cause

Other

Distribution Pattern

Arkansas, Florida, Texas, North Carolina, Wisconsin and Japan.

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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