Recall Z-2213-2016 ยท FQM Bandage, Elastic
Amd-Ritmed, Inc.
AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./15 cm x 3.7 cm, Reorder Number/Code D606, Bar code 6 86864 04230 3, Made in China -- Manufactured for & distributed by: AMD-RITMED INC. Montreal Quebec H8T 3J8 -- US Distribution: AMD-RITMED INC. Tonawanda, NY 14150 -- Type of packaging: 1 roll/pouch, 12 pouches/inner box, 4 inner box/case, 48 rolls per case. Conformin
| Date | Mar 30, 2016 |
| Status | Terminated |
| Reason | The product lot did not meet sterility requirements based on FDA sampling and analysis. |
| Root cause | Material/Component Contamination |
| Action | The firm, AMD-Ritmed, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated 3/30/2016 and Medical Device Recall Response Form to the US distributors/customers via e-mail. The letter described the product, problem and actions to be taken. The customers were instructed to examine your stock to determine if you have any; immediately discontinue distributing product; promptly return product via parcel post to Tonawanda/Buffalo warehouse, ATTENTION: RETURNED GOODS, AMD-Ritmed Inc., 295 Firetower Drive, Tonawanda, NY 14150; if you have further distributed the product, immediately contact your account |
| Quantity | US: 107 cases (48 rolls per case) |
| Distribution | US Distribution in states of: NY, CA, and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.