Z-0756-2017Class II

Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile Item Code...

Name: Z-0756-2017 Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile Item Code...
Creator: Covidien LLC
Published: 2016-10-14
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2016-10-14 / Terminated / root cause: packaging

FDA source

Covidien LLC began a recall of Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile Item Code: 17099 on 2016-10-14. FDA classified it as Class II and gives the reason as "Sterility of the outer surface of the container compromised due to packaging defect". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0756-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-14
Posted: 2016-12-14
Terminated: 2018-08-08
Recalling firm: Medtronic, Inc.
Product: Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile Item Code: 17099
Product code: FMH Container, Specimen, Sterile
Reason for recall: Sterility of the outer surface of the container compromised due to packaging defect.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Covidien initiated recall by letter on October 14, 2016. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Accounts requested to completed Recalled Product Return From to obtain an RGA. Questions: Contact your Medtronic representative or Customer Service at (800) 882-5878.
Quantity in commerce: 5,187,100 Units
Distribution: Nationwide Foreign: Japan
Product codes and lots: All lots starting with 3, 4, 5 and all lots from 600586264X to 613480164X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0756-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0756-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-21	2016-12-14

Product code FMH

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)