—#126459

Product

Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access to central circulation. Catalog number ASK-45703-PHF.

FDA product code: FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K071538
Affected lot / code info: MF2016829 RM2072044 RM2034076 RM2095792 RM2056629 RM3015571 RM2069733

Why it was recalled

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

Root cause (FDA determination)

Labeling False and Misleading

Action the firm took

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.

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Road, Reading, Pennsylvania 19605

Distribution

Distribution pattern: US Distribution only to MI.

Timeline

Recall initiated: 2013-07-17
Posted by FDA: 2014-05-19
Terminated: 2015-03-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126459. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.