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ReNew recallZ-0507-2018 · Microline Surgical, Inc. · initiated Jul 13, 2017

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Microline Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

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: [email protected] 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 [email protected] or contact Director of RA & QA at 978-922-9810 or email: [email protected].

Recall details

Recall number
Z-0507-2018
Status
Terminated
Initiated by the company
Jul 13, 2017
Recalling firm
Microline Surgical, Inc.
Quantity
61,769 units
Product code
GEI
FDA submissions
K962119, K974066
Distribution
Worldwide Distribution-US (Nationwide) and countries of: Australia, Brazil, Canada, Chile, China, Colombia, El Salvador, Hong Kong, India, Indonesia, Malaysia, Mexico, Panama, Peru, Argentina, South Korea, Sri Lanka, Taiwan, Thailand, Uruguay & Vietnam.

Product description

The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic surgical procedures.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

All lots of product codes: 3201,3221,3231,3241,3251,3261,3271,3281,3291,3301,3311,3321,3331,3341, 3351,3361,3371,3381,3401,3411,3421,3431  UDI's for listed lots of product codes: 3201-UDI 00811099011644,  3221-UDI 00811099011651, 3231-UDI 00811099011668, 3241-UDI 00811099011675, 3251-UDI 00811099011682, 3261-UDI 00811099011699, 3271-UDI 00811099011705, 3281-UDI 00811099011712, 3291-UDI 00811099011729, 3301-UDI 00811099011859, 3311-UDI 00811099011736, 3321-UDI 00811099011743, 3331-UDI 00811099011767, 3341-UDI 00811099011774, 3351-UDI 00811099011781, 3371-UDI 00811099011804, 3381-UDI 00811099011811, 3401-UDI 00811099011828, 3411-UDI 00811099011835, 3421-UDI 00811099011842, 3431-UDI 00811099011644

Devices named in this recall

20 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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