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Terminated

PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound

FDA Recall Z-2462-2015 · Posted 2015-08-25

Recall StatusTerminated
Product CodeLJS
Date Initiated2015-07-30
Date Terminated2018-06-28
Product Quantity52109

Reason for Recall

the catheter peel-away component hub tabs may prematurely detach. One injury reported.

Firm Action

Teleflex sent an Urgent Medical Device Recall Notificatin letters dated July 30, 2015 to their affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: 1. immediately discontinue use and quarantine any products with the catalog and lot number provided in the notice. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507 Attn: Customer Service or email it to [email protected]. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Arrow International. 3. Customers were also asked to complete the enclosed Recall Acknowledgment Form if there is no affected product, this will allow for documented receipt of this letter. For questions contact your local sales representative or Customer Service at 1-866-246-6990.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

US Nationwide Distribution and internationally to Canada

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.

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