FDAClass IIJune 20, 2012

Churchill Medical Systems recall

Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter…

Why was Churchill Medical Systems recalled?

Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Code AMS-9437CP -- lots 1112059, 1112106, 1202101, 1101505, 1101026, 1103020, 1104130, 1103190, and 1109064.

Product
Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter…
Recalling firm
Vygon Corporation
Distribution
Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.
Recall date
June 20, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls