CLASS II ONGOING Device recall · Reported 23 Aug 2023 · FDA Enforcement Report
Snowden-Pencer Mis Diamond-touch Dissector Diamond Jaw, Ratcheted recalled
Carefusion 2200 is recalling Snowden-Pencer Mis Diamond-touch Dissector Diamond Jaw, Ratcheted. The recall was initiated on 13 Jul 2023 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-2425-2023
- FDA event ID
- 92561
- Recalling firm
- Carefusion 2200, Vernon Hills, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Jul 2023
- FDA classified
- 17 Aug 2023
- Reported
- 23 Aug 2023
- Type
- Voluntary: Firm initiated
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 13 Jul 2023 | Recall initiated by company | |
| 17 Aug 2023 | Classified by FDA | +35 days |
| 23 Aug 2023 | 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
Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7071; endoscopic surgical device
Where it was distributed
US and Canada
Questions about this recall
Is Snowden-Pencer Mis Diamond-touch Dissector Diamond Jaw, Ratcheted recalled?
Yes. Carefusion 2200 recalled Snowden-Pencer Mis Diamond-touch Dissector Diamond Jaw, Ratcheted on 13 Jul 2023. The recall is Class II and its status is Ongoing. Recall number Z-2425-2023.
Why was it recalled?
Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Which lots are affected?
UDI/DI 10885403160790, Lot Numbers: L22, B23, C23
Where was it sold?
US and Canada
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.
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