Device product
AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W, Sterile -- 200 Dressings per case -- Made in China for AMD-Ritmed Inc. 1200 55th Ave., Lachine, QC H8T 3J8/295 Firetower Road, Tonawanda, NY 14150
Z-0727-2017
Product summary
- Firm
- Amd-Ritmed, Inc.
- Event
- Event 74368
- Status
- Terminated
- Classification
- Class II
- Quantity
- US: 216 cases (200 dressings per case)
- Official record key
device-enforcement:Z-0727-2017
Official wording
Reason: The lot of transparent dressing was found to be contaminated (not sterile) based on FDA sampling and analysis.
Code information: Lot 68408, expiration date 2018¿05
Distribution pattern: NY, MA, VA, TN
Derived failure modes
-
Unknown
The lot of transparent dressing was found to be contaminated (not sterile) based on FDA sampling and analysis.