Z-0818-2019Class II

Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm-

Name: Z-0818-2019 Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm-
Creator: Angiotech (Manan Medical Products, Inc.)
Published: 2018-12-18
License: https://open.fda.gov/license/

Argon Medical Devices, Inc / initiated 2018-12-18 / Terminated / root cause: manufacturing process

FDA source

Angiotech (Manan Medical Products, Inc.) began a recall of Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration on 2018-12-18. FDA classified it as Class II and gives the reason as "Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line". 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-0818-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-18
Posted: 2019-02-07
Terminated: 2020-08-23
Recalling firm: Argon Medical Devices, Inc
Product: Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
Product code: DWO Needle, Biopsy, Cardiovascular
Reason for recall: Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Argon Medical Devices notified customers on about 12/18/2018 via "Urgent - Field Safety Notice" letter. Instructions included complete and return the response form a quickly as possible, return all affected product to their Argon Wheeling facility, and to provide the recall notification to all who need to be aware within the organization as well as any organization where the affected product was distributed.
Quantity in commerce: 1,404 units
Distribution: Worldwide distribution - US Nationwide in the states of New Jersey, and countries of Mexico and South Korea.
Product codes and lots: Model Number UCIN-16-5, Lot Number LK2L

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0818-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0814-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-13	2019-02-07
Z-0815-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-13	2019-02-07
Z-0816-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-13	2019-02-07
Z-0817-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-13	2019-02-07
Z-0818-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-13	2019-02-07
Z-0819-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-13	2019-02-07
Z-0820-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-13	2019-02-07

Product code DWO

K890925Class IManan Bone Marrow Biopsy NeedleManan Medical Products, Inc. / cleared 1989-04-11

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)