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Terminated

Churchill Medical Systems Bag Access Device w/Smartsite Needleless Injection Site, Sterile, Non pyrogenic, Latex Free Product Code: KSA-140. Churchill Medical Systems, Inc. Dover, NH 03820. Intravascular administration set.

FDA Recall Z-1639-2010 · Posted 2010-05-21

Recalling FirmChurchill Medical Systems, Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2009-10-20
Date Terminated2013-03-28
Product Quantity283,900 each

Reason for Recall

Bond between the spike and needle may leak, break or detach resulting in leakage or spillage of chemotherapeutic agents

Firm Action

Churchill Medical Systems issued an "Urgent: Product Advisory Customer Notification" dated October 20, 2009 requesting return of affected product and notification to end users. For further information, contact Churchill Medical Systems at 1-603-743-5988 or via fax at 1-603-743-6328.

Root Cause

Process change control

Distribution Pattern

Distributed to Florida.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011336PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCKChurchill Medical Systems, Inc. · 2001-06-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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