—#131448

Product

Arrow Nerve Block Component, Product Code: AB-18040-N: Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.

FDA product code: CAZ — Anesthesia Conduction Kit
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K121403
Affected lot / code info: Product Number: AB-18040-N; Lot Number: RF2096425, RF2010131, RF1057898, RF0074365, RF0035689

Why it was recalled

Arrow is recalling certain lots of the Continuous Nerve Block Component, Product Code: AB-18040-N, due to a labeling inconsistency. The product lidstock incorrectly identifies the needle in the finished good as 17Ga rather than the correct 18Ga. The product included in the package is the correct 18Ga size. No injuries or illnesses have been reported.

Root cause (FDA determination)

Labeling False and Misleading

Action the firm took

An urgent medical device recall notification, dated November 11, 2014, was sent to consignees which identified the product, problem, and action to be taken. Customers with affected stock were asked to immediately discontinue use and quarantine any products with the catalog and lot number. To return product, the Recall Acknowledgement Form should be completed and faxed to 1-855-419-8507 Attn: Customer Service or email it to recalls@teleflex.com. A customer service representative will be in contact to provide instructions for the return of product. All customers were asked to complete the Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to recalls@teleflex.com.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide Distribution.

Timeline

Recall initiated: 2014-11-10
Posted by FDA: 2014-12-12
Terminated: 2016-09-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #131448. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.