Smiths Medical ASD Inc. smiths medical portex Loss of Resistance Device, REF 100/398/000 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
smiths medical portex Loss of Resistance Device, REF 100/398/000
Brand
Smiths Medical ASD Inc.
Lot Codes / Batch Numbers
Lot Numbers: 3980977, 3986734, 3994302, 3994303 and 4001003
Products Sold
Lot Numbers: 3980977, 3986734, 3994302, 3994303 and 4001003
Smiths Medical ASD Inc. is recalling smiths medical portex Loss of Resistance Device, REF 100/398/000 due to The labeling was missing information on sterilization and prohibition of reuse.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The labeling was missing information on sterilization and prohibition of reuse.
Recommended Action
Per FDA guidance
The firm notified their consignees of the recall by email on 12/08/2021. Distributors were directed to notify their consignees. The firm is seeking return of the product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026