—#96674

Product

Super Arrow-Flex(R) PSI Set Intended for use in the hospital catheterization laboratory for the percutaneous introduction of various devices into veins and/or arteries in a variety of diagnostic and therapeutic procedures

FDA product code: DYB — Introducer, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K780532
Affected lot / code info: Part No: CL-07645, Lot No: CF0014630

Why it was recalled

Packaging may have been compromised, and sterility of product cannot be guaranteed.

Root cause (FDA determination)

Other

Action the firm took

The firm, Teleflex Medical thru its subsidiary Arrow International, Inc., sent an "Urgent Field Safety Notice" letter dated December 20, 2010, with Field Acknowledgement form to all customers. The letter described the product, problem and action to be taken by the customers. The letter instructed the customers to check their stock for affected product, cease use and distribution of product and quarantine all products from affected lot immediately; contact their local Teleflex Medical Customer Service/Sales Rep (or Distributor) for a return authorization number prior to filling out the FIELD SAFETY CORRECTIVE ACTION ACKNOWLEDGEMENT AND STOCK STATUS FORM; and complete and return the form immediately by email. If you do not have the product from the affected lot, indicate it on the form and fax it to your local Teleflex Medical Customer Service/Sales Rep (or Distributor). The Teleflex Medical Customer Service/Sales Rep (or Distributor) will coordinate the product return with the customer. If you have any questions, please contact the Regulatory Affairs Project Manager at 610-378-0131 ext 3318 or email: Jody.Cadd@teleflexmedical.com.

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Road, Reading, Pennsylvania 19605

Distribution

Distribution pattern: International distribution only: countries include: Austria, Belgium, Czech Republic, Germany, Greece, Italy, and Luxembourg.

Timeline

Recall initiated: 2010-12-20
Posted by FDA: 2011-01-21
Terminated: 2014-09-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #96674. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.