Recall Z-2048-2011 ยท DYB Introducer, Catheter
Arrow International Inc
Percutaneous Sheath Introducer Kit Intended usage: Permits venous access and catheter introduction to the central circulation system
| Date | Mar 25, 2011 |
| Status | Terminated |
| Reason | Labeling discrepancy - the outer corrugate label as well as a card inside the package state the product contains dry natural rubber - this is not duplicated on the unit packaging. |
| Root cause | Other |
| Action | The firm, Arrow International, sent an "URGENT MEDICAL DEVICE NOTIFICATION" letter dated March 25, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately quarantine any products with the listed lot numbers; complete and return the Immediate Attention Request form via fax to 800-343-2935 indicating how much product they have in stock and whether they need labels. In the event that an alternative approach is needed, the customers are to contact Arrow Customer Service for more information. Once the labels have been |
| Quantity | 840 |
| Distribution | Nationwide distribution: USA including states of: PA and NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K780532 | PERCUTANEOUS SHEATH INTRODUCER KIT Arrow Intl., Inc., Apr 21, 1978 |