Recall Z-2709-2026 ยท KNW Instrument, Biopsy
Argon Medical Devices, Inc
Bone Marrow Tray, REF: CB0033TL; CB0355TLA
| Date | Jul 10, 2026 (initiated Jun 1, 2026) |
| Status | Open, Classified |
| Reason | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. |
| Root cause | Material/Component Contamination |
| Action | On 6/1/2026, correction notices were sent to customers who were asked to do the following: 1) Do not use the affected Lidocaine vials included in affected Kits and Sets in scope of this notice 2) Review your inventory for any product covered by this Medical Device Notification. If any items from the affected lot are identified: - Place a copy of this notice with the affected product - Apply the enclosed stickers to the packaging (kit) to clearly identify the item and remind users to discard affected lidocaine. 3) At the point of use, upon opening the kit, discard the affected Lidocaine vials |
| Quantity | 680 |
| Distribution | Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980196 | MD TECH BIOPSY SET FOR BONE AND BONE MARROW Medical Device Technologies, Inc., Feb 3, 1998 |