Z-1859-2016Class II

Vistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7321

Name: Z-1859-2016 Vistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7321
Creator: Covidien LLC
Published: 2016-03-03
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2016-03-03 / Terminated / root cause: packaging

FDA source

Covidien LLC began a recall of Vistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7321 on 2016-03-03. FDA classified it as Class II and gives the reason as "Compromised sterility due to breach of barrier". 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-1859-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-03
Posted: 2016-05-31
Terminated: 2017-06-15
Recalling firm: Medtronic, Inc.
Product: Vistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7321
Product code: LRS I.V. Start Kit
Reason for recall: Compromised sterility due to breach of barrier
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Covidien initiated recall by letter on March 4, 2016. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Any questions or concerns, contact your Medtronic representative or Customer Service at (800) 882-5878
Quantity in commerce: 199488
Distribution: Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.
Product codes and lots: All lots beginning with 100000009962 through lot 15J163262X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1859-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1847-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-31
Z-1848-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-31
Z-1849-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-31
Z-1850-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-31
Z-1851-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-31
Z-1852-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-31
Z-1853-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-31
Z-1854-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-31
Z-1855-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-31
Z-1856-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-31
Z-1857-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-31
Z-1858-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-31
Z-1859-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-31

Product code LRS

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)