Z-2213-2016Class II

AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./15 cm x 3.7 cm, Reorder...

Name: Z-2213-2016 AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./15 cm x 3.7 cm, Reorder...
Creator: Amd-Ritmed, Inc.
Published: 2016-03-30
License: https://open.fda.gov/license/

Amd-Ritmed, Inc. / initiated 2016-03-30 / Terminated / root cause: manufacturing process

FDA source

Amd-Ritmed, Inc. began a recall of 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... on 2016-03-30. FDA classified it as Class II and gives the reason as "The product lot did not meet sterility requirements based on FDA sampling and analysis". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2213-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-30
Posted: 2016-07-15
Terminated: 2016-07-15
Recalling firm: Amd-Ritmed, Inc.
Product: 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. Conforming bandages used to cover and protect wounds from further injuries and contamination. This type of product fits all parts of the body without restrictive movement. To be used in health care facilities.
Product code: FQM Bandage, Elastic
Reason for recall: The product lot did not meet sterility requirements based on FDA sampling and analysis.
Root cause tag: manufacturing process
FDA 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 accounts, advise them of the recall situation and have them return their outstanding stock, and complete and return the enclosed MEDICAL DEVICE RECALL RETURN RESPONSE-Acknowledgment & Receipt Form via email to : [email protected] or fax to: 1-866-871-3455, ATTN: AMD-Ritmed Customer Service. If you have any questions, please contact us at (1-800-445-0340) or at AMD Customer Service [email protected].
Quantity in commerce: US: 107 cases (48 rolls per case)
Distribution: US Distribution in states of: NY, CA, and TN.
Product codes and lots: Lot 64155, Expiration Date 2017-06

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2213-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2213-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-15

Product code FQM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)