FDA Medical Device Recalls (openFDA)
Amd-Ritmed, Inc.: 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
- Recall number
- Z-0727-2017
- Recalling firm
- Amd-Ritmed, Inc.
- 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
- Status
- Terminated
- Initiated
- 2016-06-08
- Posted
- 2016-12-08
- Terminated
- 2017-02-24
- Reason
- The lot of transparent dressing was found to be contaminated (not sterile) based on FDA sampling and analysis.
- Root cause
- Material/Component Contamination
- Action
- URGENT: MEDICAL DEVICE RECALL Letter (dated 6/8/2016) was e-mailed to the consignees on 6/8/2016. The recall is being conducted to the retail level. For questions. please contact AMD Customer Service by phone at 1-800-445-0340 or by e-mail at contactus@amdritmed.com.
- Quantity
- US: 216 cases (200 dressings per case)
- Distribution
- NY, MA, VA, TN
- Lot, serial or model codes
- Lot 68408, expiration date 2018¿05
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NAC
- Firm FEI
- 1319092
- Firm city
- Tonawanda
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28