smiths medical portex Loss of Resistance Device recall: Labeling Error
smiths medical portex Loss of Resistance Device, REF 100/398/000
Why was smiths medical portex Loss of Resistance Device recalled?
The labeling was missing information on sterilization and prohibition of reuse.
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?
Lot Numbers: 3980977, 3986734, 3994302, 3994303 and 4001003
- Product
- smiths medical portex Loss of Resistance Device, REF 100/398/000
- Recalling firm
- Smiths Medical ASD Inc.
- Quantity
- 3420 devices
- Distribution
- Canada. Belgium, Great Britain, Ireland, Czech Republic, Spain, France, Switzerland, Israel, Germany, Sweden, Italy, New Zealand, Australia, South Africa, Netherlands, Slovenia, United Arab Emirates
- Recall date
- October 27, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)