Recall Z-0355-2016
Procedure Products, Inc. · initiated October 27, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Lot 9184-A
Reason for recall
The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle
FDA-determined cause: Nonconforming Material/Component
Action taken
The firm sent the Urgent Medical Device Recall letter to their consignees via email on 10/27/15. Customers with questions can call Doug Rowley at 360-693-1832 or send email to doug@procedureproducts.com
Details
- Recall number
- Z-0355-2016
- Initiated
- October 27, 2015
- Posted by FDA
- December 1, 2015
- Terminated
- April 1, 2016
- Product code
- DRE – Dilator, Vessel, For Percutaneous Catheterization
- Quantity
- 1100 pieces
- Distribution
- Distributed in the states of MT and NY.
- Recalling firm
- Procedure Products, Inc., Vancouver, WA