CLASS II Device recall · Reported 7 Sep 2016 · FDA Enforcement Report
Geo-Med, Turp/Cysto Pack Pgybk recalled by DeRoyal Industries
DeRoyal Industries is recalling Geo-Med, Turp/Cysto Pack Pgybk, distributed in Louisiana, Tennessee. The recall was initiated on 11 Aug 2016 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-2678-2016
- FDA event ID
- 74927
- Recalling firm
- DeRoyal Industries, Powell, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Aug 2016
- FDA classified
- 26 Aug 2016
- Reported
- 7 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 11 Aug 2016 | Recall initiated by company | |
| 26 Aug 2016 | Classified by FDA | +15 days |
| 7 Sep 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap. The BARD(TM) component is being recalled for a possible slit defect on the package that may affect the component's sterility.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit.
Where it was distributed
Distributed in LA and TN.
Questions about this recall
Is Geo-Med, Turp/Cysto Pack Pgybk recalled?
Yes. DeRoyal Industries recalled Geo-Med, Turp/Cysto Pack Pgybk on 11 Aug 2016. The recall is Class II and its status is Terminated. Recall number Z-2678-2016.
Why was it recalled?
The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap. The BARD(TM) component is being recalled for a possible slit defect on the package that may affect the component's sterility.
Which lots are affected?
Lot Number 40259236
Where was it sold?
Distributed in LA and TN.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from DeRoyal Industries
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|---|---|---|---|---|---|
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