Radial Artery Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation. The safety feature is intended to help minimize the risk of sharps injuries when using the device.
FDA Recall Z-2741-2016 · Posted 2016-09-07
Advertisement
Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeDQX
Date Initiated2016-08-08
Date Terminated2017-08-22
Product Quantity690 kits
Reason for Recall
Shipping carton labeling error.
Firm Action
Teleflex sent an Urgent Medical Device Recall Notification letter dated August 23, 2016, via FED-Ex 2 Day Air. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine all affected products. Instructions for the products return were provided in the firm's recall notification letter. Customers were asked to complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to [email protected]. Customers with questions were instructed to call 1-866-246-6990.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution to OH, IN, TN, NC, and KY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement