Device Recall ReNew Reusable Grasper and Dissector Tips 의 리콜

Recall

78754

Class 2

Z-0507-2018

2017-07-13

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160285

The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. if a split occurs, the heat-shrink could fall off during a surgical procedure and if cautery is needed, there is a potential for burn due to insulation failure.

The firm, Microline Surgical, Inc., sent a "URGENT: MEDICAL DEVICE RECALL" letter dated July 13, 2017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately determine if you are in possession of the product and stop use; quarantine all products both new un-opened Reusable Tips AND Reusable Tips that have been used or are in current use (regardless of whether you have observed the malfunction); If you are a distributor or further distributed this product, we require that you immediately remove affected products from inventory and stop sales and shipping; identify customers immediately and notify them of this product recall; and all customers/distributors complete and return the MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form (even if you have never received any of these products or have none in stock) by E-MAILING A SCANNED COPY TO: ReusableTipRecall@microlinesurgical.com or Fax to: 978-522-8490, ATTN: Reusable Tip Recall, or MAIL TO: Microline Surgical, Inc, 50 Dunham Road, Suite 1500, Beverly, MA 01915, ATTN: Recall Department. Microline has discontinued manufacture of the affected ReNew Reusable Tips and has initiated a ship-hold and new orders-hold for these products. For more information, please email ReusableTipRecall@microlinesurgical.com or contact Director of RA & QA at 978-922-9810 or email: mleighton@microlinesurgical.com.