Z-2048-2011

Percutaneous Sheath Introducer Kit Intended usage: Permits venous access and catheter introduction to the...

Name: Z-2048-2011 Percutaneous Sheath Introducer Kit Intended usage: Permits venous access and catheter introduction to the...
Creator: Arrow International Inc
Published: 2011-03-25
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2011-03-25 / Terminated / root cause: labeling and UDI

FDA source

Arrow International Inc began a recall of Percutaneous Sheath Introducer Kit Intended usage: Permits venous access and catheter introduction to the central circulation system on 2011-03-25. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2048-2011
Status: Terminated
Initiated: 2011-03-25
Posted: 2015-06-26
Terminated: 2014-01-29
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Percutaneous Sheath Introducer Kit Intended usage: Permits venous access and catheter introduction to the central circulation system
Product code: DYB Introducer, Catheter
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.
Root cause tag: labeling and UDI
FDA 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 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.
Quantity in commerce: 840
Distribution: Nationwide distribution: USA including states of: PA and NJ.
Product codes and lots: Catalog # PH-09806 -- Lot numbers RF7101122, RF8069650, F8124062, RF0017914, RF0091936

Product code DYB

K780532Class IIPercutaneous Sheath Introducer KitArrow Intl., Inc. / cleared 1978-04-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)