Z-1194-2017Class II

BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for the purpose of harvesting bone...

Name: Z-1194-2017 BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for the purpose of harvesting bone...
Creator: Argon Medical Devices, Inc
Published: 2017-01-18
License: https://open.fda.gov/license/

Argon Medical Devices, Inc / initiated 2017-01-18 / Terminated / root cause: manufacturing process

FDA source

Argon Medical Devices, Inc began a recall of BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for the purpose of harvesting bone and/or bone marrow specimens on 2017-01-18. FDA classified it as Class II and gives the reason as "The recalling firm received a complaint from one of their customers of a potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray". 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-1194-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-18
Posted: 2017-02-13
Terminated: 2017-05-17
Recalling firm: Argon Medical Devices, Inc
Product: BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for the purpose of harvesting bone and/or bone marrow specimens
Product code: KNW Instrument, Biopsy
Reason for recall: The recalling firm received a complaint from one of their customers of a potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Argon Medical Devices, Inc. is sending an Urgent Product Recall Notice letter dated January 17, 2017, by registered mail to all affected customers. Customers were asked to determine if their inventory shows the package defect and discontinue use of the device and promptly return the affected product. For questions regarding this recall call 903-403-0749.
Quantity in commerce: 497 boxes
Distribution: Worldwide Distribution - US (nationwide) and Internationally to Switzerland, Canada, Australia, New Zealand, Ecuador, Colombia, and Japan.
Product codes and lots: lots: 11156986, 11158618, 11158620

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1194-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1194-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-22	2017-02-13
Z-1195-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-22	2017-02-13
Z-1196-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-22	2017-02-13

Product code KNW

K980196Class IIMd Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. / cleared 1998-02-03

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)