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Medical Devices / Regulatory Affairs / Postmarket Safety

MHRA Issues Safety Alert for Arrow International’s TransRadial Artery Access Kit

Dec. 16, 2013

The UK’s Medicines and Healthcare products Regulatory Agency issued a medical device alert Friday for Arrow International’s TransRadial artery access kit, due to the possibility that the introducer needles could become partially or fully occluded. This could cause treatment to the patient to be delayed or missed, putting them at risk, the agency says.

The alert follows a voluntary recall and field safety notice initiated by Arrow in October. But, according to the MHRA, the company had “not received sufficient confirmation” that customers and distributors had received and acted on the recall notice.

Affected by the recall and MHRA alert are lots AA-10407-1, AA-10524, AA-15511-3, AA-11041101, AA-110607-1, AA-15511-S, AA-10507-1, AA-10611-1, AA-15611-3, AA-10511-1, AA-10624-1 and AA-15611-S.

Arrow is asking users to identify and quarantine affected kits and return them to Teleflex Medical, its parent company.

The MHRA has set a Dec. 23 deadline for Arrow to put a corrective plan in place. The deadline for completing the field correction is Jan. 17.

View the recall notice at http://www.fdanews.com/ext/resources/files/12/12-13-13-ArrowRecall.pdf. The MHRA’s medical device alert is at http://www.fdanews.com/ext/resources/files/12/12-13-13-MHRAAlert.pdf. —Lena Freund

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