Z-1639-2010

Churchill Medical Systems Bag Access Device w/Smartsite Needleless Injection Site, Sterile, Non pyrogenic...

Name: Z-1639-2010 Churchill Medical Systems Bag Access Device w/Smartsite Needleless Injection Site, Sterile, Non pyrogenic...
Creator: Churchill Medical Systems, Inc.
Published: 2009-10-20
License: https://open.fda.gov/license/

Vygon Mfg / initiated 2009-10-20 / Terminated

FDA source

Churchill Medical Systems, Inc. began a recall of Churchill Medical Systems Bag Access Device w/Smartsite Needleless Injection Site, Sterile, Non pyrogenic, Latex Free Product Code: KSA-140. Churchill Medical... on 2009-10-20. The reason FDA records is "Bond between the spike and needle may leak, break or detach resulting in leakage or spillage of chemotherapeutic agents". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1639-2010
Status: Terminated
Initiated: 2009-10-20
Posted: 2010-05-21
Terminated: 2013-03-28
Recalling firm: Vygon Mfg
Product: 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.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Bond between the spike and needle may leak, break or detach resulting in leakage or spillage of chemotherapeutic agents
FDA root cause: Process change control
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.
Quantity in commerce: 283,900 each
Distribution: Distributed to Florida.
Product codes and lots: Lot Numbers: 903005, 904057, 904060, 904061, 904062, 904063, 905089, 905090, 905091, 906199, 907005, 907006, 907007, 909014, 909015, 909016, 909017, 909018, 909026, 909031, 909032, 909033, 909034, 909035, 909036 and 909037.

Product code FPA

K011336Class IIPrimary Solution Set with Universal Spike, Injection Site and Male Luer LockChurchill Medical Systems, Inc. / cleared 2001-06-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)