Device product
Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic
Z-0687-2020
Product summary
- Event
- Event 84293
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3260 eaches (5 eaches per retail box)
- Official record key
device-enforcement:Z-0687-2020
Official wording
Reason: Elasto-Gel Wound Dressing may be contaminated with mold.
Code information: Lot 1917802
Distribution pattern: CA, GA, IL, KS, NY, OH, TN, TX, VA
Derived failure modes
-
Microbial contamination
contaminated with mold