The Recall Desk
LowFDA (Devices)·Z-0936-2018·Announced 2018-03-21

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.

What this means for you

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 a
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.

Same manufacturer · Medtronic Minimally Invasive Therapies Group

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