Z-1251-2016Class II

IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6...

Name: Z-1251-2016 IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6...
Creator: Amd Ritmed
Published: 2016-02-24
License: https://open.fda.gov/license/

Amd-Ritmed, Inc. / initiated 2016-02-24 / Terminated / root cause: manufacturing process

FDA source

Amd Ritmed began a recall of IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6 86864 04351 5, 96 per case (8 boxes x 12 sterile... on 2016-02-24. FDA classified it as Class II and gives the reason as "Product does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus". 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-1251-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-24
Posted: 2016-03-25
Terminated: 2016-07-08
Recalling firm: Amd-Ritmed, Inc.
Product: IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6 86864 04351 5, 96 per case (8 boxes x 12 sterile bandages), Single Use To cover and protect the primary dressing that is in contact with wounds from further injuries, contamination and infection. To be used in health care facilities
Product code: MHW Dressing, Compression
Reason for recall: Product does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: AMD Ritmed sent an Urgent - Medical Device Recall letter dated February 25, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are asked to examine all stocks immediately to determine if any of the affected product is on hand. If so, please discontinue distributing the product immediately and promptly return. If customers further distributed any of the product, please immediately contact your accounts advise them of the recall situation, and have them return their outstanding recalled stocks to you. Return these stocks as indicated above. Please return the enclosed response form immediately providing the requested information by fax 1-866-871-3455 or by email: [email protected]. Customers with questions can call 1-800-445-0340 or email AMD Customer Service: [email protected].
Quantity in commerce: 126 cases total (87 cases domestically and 39 cases internationally)
Distribution: US Distribution including Puerto Rico and to the states of : DE, FL, KY, MI, NE and NJ., and Internationally to the country of Canada.
Product codes and lots: Lot 63927, expiration 2017-04

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1251-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1251-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-25

Product code MHW

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)