ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC Ki

FDA device recall Z-0207-2016 · posted 2015-11-04 · Terminated

Recall details

Recalling firm

Arrow International Inc

Reason for recall

Possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter. Although the issue does not pose a significant risk to the patient, it may cause a delay of treatment when placing the catheter.

Action taken

Arrow International sent an Urgent Medical Device Recall Notification letter dated October 16, 2015, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignees. Consignees were instructed to immediately discontinue use and quarantine any effected products. Consignees were instructed to return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507 Attn: Customer Service or email it to recalls@teleflex.com. A customer service representative will contact consignees with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Arrow International. For consignees with no affected product, should also complete the enclosed Recall Acknowledgement Form. For questions customers should call 1-866-246-6990.

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

LJS

Quantity affected

12,157

Distribution

World Wide Distribution - US including AR, AL, TX, MA, CA, IA, MO, NY, AL, VA, RI, IN, TN, FL, KY, NH, SC, MD, WA, OK, IL, ME, OR, OH, PA, MI, KS, LA, TN, WV, NE, NJ, NV, GA, SD, CT, MS, CO, and Inter

Date initiated

2015-10-16

Date posted

2015-11-04

Date terminated

2017-11-09

Location

Reading, PA

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