Reported Jan 14, 2015 · Terminated
CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc. Part Number…
Kci USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: KCI USA, INC. · 12930 IH 10 West · San Antonio, TX · 78249
Is this the product you have?
- CelluTome Epidermal Harvesting System Harvester (5.0
- CM) STERILE EO Rx Only Manufactured forKCI USA, Inc. Part Number CT-H50 or CT-H25 The CelluTome Epidermal Harvesting System is intended to reproducibly cut a thin skin graft for autologous skin grafting
- Lot codes and dates
- CT-H25 lot numbers
32499800003249990000325001000025378722556866
- CT-H50 lot numbers
3249660000324984000032500500002498886251087425378792545871
- CT-H25 lot numbers
- Amount recalled
- 1,139/5 Packs
Where it was sold
- Nationwide
Why it was recalled
KCI has received reports that, in a small number of cases, the CelluTome Harvester (a component of the CelluTome Epidermal Harvesting System), blades have the potential to drift during shipping and could prematurely protrude into openings of harvester top plate.
This product could cause temporary or reversible health problems — stop using it.
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