Super Arrow-Flex(R) PSI Set Intended for use in the hospital catheterization laboratory for the percutaneous introductio

FDA device recall Z-0936-2011 · posted 2011-01-21 · Terminated

Recall details

Recalling firm

Arrow International Inc

Reason for recall

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

Action taken

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.

Root cause

Other

Status

Terminated

Product code

DYB

Quantity affected

320 units

Distribution

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

Date initiated

2010-12-20

Date posted

2011-01-21

Date terminated

2014-09-25

Location

Reading, PA

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