Z-0355-2016 Class II Terminated
FDA device recall Z-0355-2016 was initiated by Procedure Products, Inc. on October 27, 2015 and is designated Class II. Reason for recall: The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle The recall status is terminated (terminated April 1, 2016). Affected quantity: 1100 pieces.
Recall Details
- Product Type
- Devices
- Report Date
- December 9, 2015
- Initiation Date
- October 27, 2015
- Termination Date
- April 1, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1100 pieces
Product Description
U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-sterile, and intended for further processing. Needles are packaged in zipper-bags, 300 pieces per bag, with shipment occurring in a corrugated cardboard box. Needles consist of a stainless steel cannula with a molded plastic hub. This needle is intended to be placed over the guidewire to enlarge the opening in the vessel. Vessel dilator, for percutaneous catheterization.
Reason for Recall
The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle
Distribution Pattern
Distributed in the states of MT and NY.
Code Information
Lot 9184-A