Recall Z-0936-2011 ยท DYB Introducer, Catheter
Arrow International Inc
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
| Date | Jan 21, 2011 (initiated Dec 20, 2010) |
| Status | Terminated |
| Reason | Packaging may have been compromised, and sterility of product cannot be guaranteed. |
| Root cause | Other |
| Action | 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 |
| Quantity | 320 units |
| Distribution | International distribution only: countries include: Austria, Belgium, Czech Republic, Germany, Greece, Italy, and Luxembourg. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K780532 | PERCUTANEOUS SHEATH INTRODUCER KIT Arrow Intl., Inc., Apr 21, 1978 |