Z-2189-2015Class II

T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G...

Name: Z-2189-2015 T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G...
Creator: Argon Medical Devices, Inc
Published: 2015-06-18
License: https://open.fda.gov/license/

Argon Medical Devices, Inc / initiated 2015-06-18 / Terminated / root cause: packaging

FDA source

Argon Medical Devices, Inc began a recall of T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBMNJ1104TL; Bone Marrow... on 2015-06-18. FDA classified it as Class II and gives the reason as "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 packaging.

Recall record

Recall number: Z-2189-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-18
Posted: 2015-07-21
Terminated: 2016-06-23
Recalling firm: Argon Medical Devices, Inc
Product: T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBMNJ1104TL; Bone Marrow Biopsy Needle 13G x 4, Part Number DBMNJ1304
Product code: KNW Instrument, Biopsy
Reason for recall: 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: packaging
FDA root cause: Packaging process control
Action: The recalling firm's sales force was notified of the recall on 6/17/15. The recalling firm will begin to send out Urgent Medical Device Recall letters by registered mail to affected customers on 6/18/15. Customers are instructed to inspect and quarantine and return any affected product and complete the Recal Response Form.
Quantity in commerce: 10290 units
Distribution: US
Product codes and lots: Lot Numbers: 11088295, 11088596, 11088597, 11089105, 11089366, 11094182, 11094681, 11094912, 11095381, 11095844, 11095845, 11095951, 11096558, 11097278, 11097504, 11098024, 11098647, 11099173

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2189-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2188-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21
Z-2189-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-21

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)