CLASS II Device recall · Reported 21 Mar 2018 · FDA Enforcement Report
Argyle Suction Tubing (Product # 8888301515) Argyle Suction recalled
Medtronic Minimally Invasive Therapies Group is recalling Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an extruded tube, distributed nationwide in the US. The recall was initiated on 24 Oct 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0936-2018
- FDA event ID
- 79352
- Recalling firm
- Medtronic Minimally Invasive Therapies Group, Mansfield, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Oct 2017
- FDA classified
- 15 Mar 2018
- Reported
- 21 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 24 Oct 2017 | Recall initiated by company | |
| 15 Mar 2018 | Classified by FDA | +142 days |
| 21 Mar 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect packaging. In one lot of Argyle Suction Tubing, the pouch may be incorrectly labeled as the Salem Sump Dual Lumen Stomach Tube. This product may have been distributed within the case of Argyle Suction Tubing.
Product as listed by the FDA
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 and also includes a male connector that can be used for devices designed with female connectors, This product is sterile, non-conductive and latex free.
Where it was distributed
USA (nationwide) Distribution
Questions about this recall
Why was it recalled?
Incorrect packaging. In one lot of Argyle Suction Tubing, the pouch may be incorrectly labeled as the Salem Sump Dual Lumen Stomach Tube. This product may have been distributed within the case of Argyle Suction Tubing.
Which lots are affected?
710016864X
Where was it sold?
USA (nationwide) Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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