CLASS II Device recall · Reported 15 Jul 2015 · FDA Enforcement Report
Upper Extremity Pack - contains Devon Light Glove Used recalled
Stradis Healthcare is recalling Upper Extremity Pack - contains Devon Light Glove Used during surgery, distributed nationwide in the US. The recall was initiated on 20 Apr 2015 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-2042-2015
- FDA event ID
- 71130
- Recalling firm
- Stradis Healthcare, Lawrenceville, GA
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 20 Apr 2015
- FDA classified
- 7 Jul 2015
- Reported
- 15 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Masks, Gloves & PPE
Timeline
| 20 Apr 2015 | Recall initiated by company | |
| 7 Jul 2015 | Classified by FDA | +78 days |
| 15 Jul 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Product as listed by the FDA
Upper Extremity Pack - contains Devon Light Glove Used during surgery
Where it was distributed
Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
Nationwide AlaskaAlabamaCaliforniaDelawareFloridaGeorgiaHawaiiIdahoIllinoisIndianaKansasKentuckyMassachusettsMarylandMaineMichiganMissouriMississippiNorth CarolinaNew Jersey
Questions about this recall
Is Upper Extremity Pack - contains Devon Light Glove Used during surgery recalled?
Yes. Stradis Healthcare recalled Upper Extremity Pack - contains Devon Light Glove Used during surgery on 20 Apr 2015. The recall is Class II and its status is Completed. Recall number Z-2042-2015.
Why was it recalled?
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
Which lots are affected?
Pack 888-2606
Where was it sold?
Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
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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