PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: July 29, 2015 Initiated: June 18, 2015 #Z-2189-2015

Product Description

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

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.

Details

Units Affected
10290 units
Distribution
US
Location
Athens, TX

Frequently Asked Questions

What product was recalled?
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. Recalled by Argon Medical Devices, Inc. Units affected: 10290 units.
Why was this product recalled?
Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 29, 2015. Severity: Moderate. Recall number: Z-2189-2015.