Medtronic Recalls Argyle Suction Tubing Due to Incorrect Packaging Labeling
Medtronic is recalling 58,954 units of Argyle Suction Tubing because some pouches may be incorrectly labeled as Salem Sump Dual Lumen Stomach Tubes.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly identifies the issue as 'Incorrect packaging' and labeling, which aligns with the rubric criteria for Low severity (packaging-only problems) as no physical defect or reported injury is mentioned.
Plain-English summary
Medtronic Minimally Invasive Therapies Group is recalling 58,954 units of Argyle Suction Tubing (Product # 8888301515). The recall is due to a packaging error where the pouch for the Argyle Suction Tubing may be incorrectly labeled as a Salem Sump Dual Lumen Stomach Tube.
The Argyle Suction Tubing is an extruded tube used as an extension for different types of devices in an operating room. It is sterile, non-conductive, and latex-free. The affected product may have been distributed within the case of Argyle Suction Tubing.
The recall covers distribution within the USA. Healthcare facilities and consumers should check their inventory for this specific product and stop using any units with the incorrect labeling.
The recalled product
- Product
- Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an extruded tube used as an extension for different types of devices in an operating room, bonded with 2 female sure grip connectors at each end of the tube to facilitate the plug/ insertion of the device…
- Manufacturer
- Medtronic Minimally Invasive Therapies Group
- Category
- Medical Device — Surgical Tubing
- Hazard
- Affected units
- 58,954
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 710016864X
Distribution
Distributed nationwide across the United States.
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