Percutaneous Sheath Introducer Kit Intended usage: Permits venous access and catheter introduction to the central circulation system
FDA Recall Z-2048-2011 · Posted None
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Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeDYB
Date Initiated2011-03-25
Date Terminated2014-01-29
Product Quantity840
Reason for Recall
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.
Firm 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 received and applied the product can be released from quarantine.
An Arrow's Sales Representative will pay a personal visit to their customers and obtain the quantity and the amount of labels they need.
If you have any other questions, feel free to contact your local sales representative or Customer Service at 866-396-2111.
Root Cause
Other
Distribution Pattern
Nationwide distribution: USA including states of: PA and NJ.
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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