Device Recall Arrow WH02220 Epidural Catheterization Kit with FlexTip Plus(R) Catheter 의 리콜

Recall

57259

Class 2

Z-1012-2011

2010-11-11

2011-02-01

Terminated

United States

2012-07-05

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95692

Sterility may be compromised.

The firm, Arrow International, issued an "URGENT MEDICAL DEVICE RECALL" letter dated November 11, 2010 to their consignees/customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to check their inventory for the affected products, cease use and distribution, quarantine all affected product immediately, return any affected product freight collect along with the completed form via mail to: Arrow International, Inc., 312 Commerce Place, Asheboro, NC 27203, Attn: Asheboro Quality Assurance Manager, and complete and return the FIELD SAFETY CORRECTIVE ACTION ACKNOWLEDGEMENT AND STOCK STATUS FORM via fax to: 800-343-2935. If you require additional information or clarification regarding this matter, please contact your sales representative, or Arrow's Customer Service Department at 866-396-2111.