Retiro De Equipo (Recall) de Device Recall Arrowgard Blue and Arrowgard Blue

Recall

67833

Class 2

Z-1633-2014

2013-07-17

2014-05-19

Terminated

United States

2015-03-30

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126459

The labeling states that the kit contains introducer needle: echogenic 18 ga. x 2.5 (6.35cm) xtw and 5ml arrow raulerson spring-wire introduction syringe; however, the kit contains, and should state, introducer needle: 18 ga. x 2.5 (6.35cm) xtw and 5ml arrow raulerson spring-wire introduction syringe. as a result of this labeling inconsistency, if the clinician were to place the needle under x-r.

Arrow sent an Urgent Medical Device Recall Notification letter dated July 17, 2013, was sent to the customer requesting they discontinue use and quarantine any remaining affected product for return to Arrow. Our records indicate that you have received products that are subject to this voluntary recall. We are now asking that you take the following actions: 1. If you have affected stock, immediately discontinue use and quarantine any products with the product and lot numbers listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-800-343-2935, Attn: Customer Service. This will allow us to document the amount of product you have on hand for return. Your sales representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions and assistance for the return of product to Arrow International. 3. If you have no affected stock, please complete the 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.