Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter - Catalog numb

FDA device recall Z-1823-2012 · posted 2012-06-19 · Terminated

Recall details

Recalling firm

Arrow International Inc

Reason for recall

Arrow is recalling the product due to the possibility of voids in the catheter hub which could lead to an interlumen crossover.

Action taken

Arrow International sent a Urgent Medical Device Recall Notification letter dated June 11, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to take the following action: 1. If you have affected stock, immediately discontinue use and quarantine any products with the catalog and lot numbers listed. 2. To return product complete the enclosed Recall Acknowledgement Form and fax to 1-800-343-2935, Attn: Customer Service. This will allow us to document the amount of the product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization ( RGA) Number and will provide instructions for the return of product to Arrow International. 3. If you have no affected stock, please complete t he enclosed Recall Acknowledgment Form and fax it to 1-800-343-2935, Attn: Customer Service. This will allow us to document your receipt of this letter. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-800-343-2935.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FOZ

Quantity affected

1,085

Distribution

USA (nationwide) AL, AZ, AR, CA, CO, FL, GA, IL, IN, KS, LA, MA, MI, MO, NV, NH, NC, OH, PA, TX, VA, WA, and WI.

Date initiated

2012-06-07

Date posted

2012-06-19

Date terminated

2014-04-03

Location

Reading, PA

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