.045 X 6 ST Guide Wire recall
.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 diameter. .054 X 7 ST Guide Wire…
Why was .045 X 6 ST Guide Wire recalled?
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).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
.045 X 6 ST Guide Wire Lot number: 391681 .054 X 7 ST Guide Wire Lot number: 391680
- Product
- .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 diameter. .054 X 7 ST Guide Wire…
- Recalling firm
- Acumed LLC
- Quantity
- 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.
- Recall date
- March 22, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)