Retiro De Equipo (Recall) de Device Recall VAD Kit Reorder

Recall

57661

Class 2

Z-1013-2011

2010-12-06

2011-02-01

Terminated

United States

2011-02-16

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96980

The firm is conducting a recall of kits that contain the monoject prefill advanced flush syringes containing heparin. the syringes are under recall by their manufacturer coviden because of testing that showed "that the crude heparin used to produce a specific batch of purified heparin sodium usp contained low level of over-sulfated chondroitin sulfate (oscs)".

The firm, Covidien, sent an "URGENT PRODUCT RECALL" letter dated November 12, 2010, to affected customers via Certified Mail, Return Receipt Requested. The letter describes the product, problem and action to be taken by the customers. The customers were instructed to examine their inventory and in-use stock to determine if they have any units of the affected product, if found, immediately remove from inventory and quarantine; if they are a distributor they were ask to notify their customers of this letter; and complete and return the PRODUCT RECALL FORM whether or not they have the affected product via fax to: 203-822-6009 or scan and email to: sdfeedback@covidien.com. Note: The returned product will be collected and counted prior to destruction or return to the vendor. Should you have any medical questions concerning this recall, please call 508-261-6393. For Customer Service questions regarding the recall, please use one of the following methods: phone 1-800-962-9888 option 1 (8am to 6:30pm Eastern); email: sdfeedback@covidien.com or fax: 302-822-6009.