.045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 inch length and 0.045 inch diame

FDA device recall Z-1483-2017 · posted 2017-03-16 · Terminated

Recall details

Recalling firm

Acumed LLC

Reason for recall

Guide wires sized as .045 X 6 were mis-packaged as .054 X 7 guide wires and those sized as .054 X 7 were mis- packaged as .045 X 6 guide wires. There is a possibility that using the incorrect guide wire size can cause health hazards, such as mal or nonunion, need for revision surgery, and histological response (if wire breaks).

Action taken

Acumed sent an Urgent Medical Device Recall letter dated 02/16/2017, to all affected customers on 02/17/2017. Consignees were instructed to follow special instructions and send survey to RecallNotification@acumed.net. Domestic customers with questions or need to return products to Acumed, please contact Acumed Agent Inventory via email AgentInventory@acumed.net to obtain a Return Material Authorization (RMA) number or contact your agent directly. International customers with questions or need to return products to Acumed, please contact Acumed Business Service via email at BusinessServices@acumed.net or call to obtain a Return Material Authorization (RMA) number. Customers with questions about recall can call 877-627-9957, choose Option 4 (US and Canada), or call 001-503-627-9957, choose option 4 (outside of US and Canada).

Root cause

Process control

Status

Terminated

Product code

LXH

Quantity affected

24 units of .045 X 6 ST Guide Wire and 25 units of .054 X 7 ST Guide Wire

Distribution

Worldwide Distribution in Great Britain, Ireland, and Japan only.

Date initiated

2017-02-17

Date posted

2017-03-16

Date terminated

2017-05-19

Location

Hillsboro, OR