CLASS II ONGOING Device recall · Reported 12 Mar 2025 · FDA Enforcement Report
DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF recalled
DeRoyal Industries is recalling DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF, distributed in Illinois, Minnesota, North Carolina, Pennsylvania, Virginia. The recall was initiated on 31 Jan 2025 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-1291-2025
- FDA event ID
- 96261
- Recalling firm
- DeRoyal Industries, Powell, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Jan 2025
- FDA classified
- 5 Mar 2025
- Reported
- 12 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 31 Jan 2025 | Recall initiated by company | |
| 5 Mar 2025 | Classified by FDA | +33 days |
| 12 Mar 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to the inner diameter of the suction tubing connector being smaller than the suction canister lid port connection. This size difference, combined with the durometer of the plastic material, makes the assembly to a suction canister lid port difficult. This could result in inadequate suction and cause a delay in patient care.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7100NS Tubing, Suction, Connector Indicated use - Fluid Movement
Where it was distributed
U.S.: IL, MN, NC, PA, and VA O.U.S.: N/A
Questions about this recall
Why was it recalled?
Due to the inner diameter of the suction tubing connector being smaller than the suction canister lid port connection. This size difference, combined with the durometer of the plastic material, makes the assembly to a suction canister lid port difficult. This could result in inadequate suction and cause a delay in patient care.
Which lots are affected?
71-C5100NS Bulk Roll Suction Connector Tubing UDI-DI code: 00749756578738 Lot Number: CNWKD04-04 71-C6100NS Bulk Roll Suction Connector Tubing UDI-DI code: 00749756578851 Lot Numbers: CNWKD04-04 CNWKD04-05 CNWKD04-10 CNWKD09-08 71-C7100NS Bulk Roll Suction Connector Tubing UDI-DI code: 00749756578967 Lot Numbers: CNWKD04-06 CNWKD04-07
Where was it sold?
U.S.: IL, MN, NC, PA, and VA O.U.S.: N/A
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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