Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The mu

FDA device recall Z-1830-2012 · posted 2012-06-26 · Terminated

Recall details

Recalling firm

Arrow International Inc

Reason for recall

Lidstock of product does not contain chlorhexidine contraindication and contains wording "contains no medication" on the label. Product insert does reflect medicated status.

Action taken

Arrow International sent an Urgent Field Corrective Action letter dated May 3, 2012 to their US consignee. The letter identified the affected product, problem and actions to be taken. The letter instructed the consignee to quarantine any affected inventory and relay the information to their Arrow Sales Representative. The letter stated that the Arrow Sales Representative would affix new labels to each kit within their inventory. The consignee was instructed to sign the Acknowledgement Form provided by the Sales Representative which would then be submitted to Arrow. An Urgent Field Safety Notice letter dated May 15, 2012 was sent to foreign consignees with field safety corrective action instructions to follow. If you require additional information or clarification regarding this matter contact your sales representative.

Root cause

Labeling mix-ups

Status

Terminated

Product code

FOZ

Quantity affected

634,912

Distribution

Worldwide Distribution - United States (nationwide) include the state of Texas. and the countries of: ARMENIA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM, CANADA, CHILE, COLOMBIA, COSTA RICA, CY

Date initiated

2012-05-03

Date posted

2012-06-26

Date terminated

2013-03-22

Location

Reading, PA

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