CLASS III Device recall · Reported 26 Sep 2012 · FDA Enforcement Report
Ultra Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File recalled
Kimberly-Clark is recalling Ultra Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File, distributed nationwide in the US. The recall was initiated on 31 Dec 2010 and the FDA has classified it as Class III.
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-2425-2012
- FDA event ID
- 62577
- Recalling firm
- Kimberly-Clark, Roswell, GA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 31 Dec 2010
- FDA classified
- 20 Sep 2012
- Reported
- 26 Sep 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Surgical Instruments
Timeline
| 31 Dec 2010 | Recall initiated by company | |
| 20 Sep 2012 | Classified by FDA | +629 days |
| 26 Sep 2012 | 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
The impacted product was not intended for commercial distribution to end users.
Product as listed by the FDA
ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown is a sterile, single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Where it was distributed
US (nationwide) including the states of CA, CO, LA, NM, OK, TX and WA.
Nationwide CaliforniaColoradoLouisianaNew MexicoOklahomaTexasWashington
Questions about this recall
Why was it recalled?
The impacted product was not intended for commercial distribution to end users.
Which lots are affected?
Product Code: 95221-35, Unit Code: 90372
Where was it sold?
US (nationwide) including the states of CA, CO, LA, NM, OK, TX and WA.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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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