The Recall Desk
HighFDA (Devices)·Z-2188-2015·Announced 2015-07-29

Argon Medical Devices Recalls Bone Marrow Aspiration Needles Due to Sterility Risk

Argon Medical Devices is recalling specific bone marrow aspiration needles because a potential defect in the blister packaging may compromise the sterility of the product.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility compromise) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Argon Medical Devices, Inc. is recalling 6,390 units of Bone Marrow Aspiration Needles (15G x 2.688 MAX, 15G x 4 MAX, and 16G x 2.688 MAX) distributed in the United States. The recall involves specific lot numbers, including 11088595, 11089104, 11089369, 11089370, 11094673, 11094679, 11095843, 11096115, 11098022, 11098023, 11098643, and 11098707.

The recall was initiated due to a potential defect in the forming of the primary package of the blister. This defect may compromise the sterility of the product inside the tray. The U.S. Food and Drug Administration has classified this as a Class II recall.

Healthcare facilities and consumers who have these specific needles should stop using them and contact Argon Medical Devices for further instructions on how to return or dispose of the product.

The recalled product

Product
Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Marrow Aspiration Needle 15G x 4 MAX, Part Number DBMNI1504; Bone Marrow Aspiration Needle 16G x 2.688 MAX, Part Number DBMNI1601
Manufacturer
Argon Medical Devices, Inc
Category
Medical Device — Surgical Instruments
Hazard
Affected units
6,390

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • Lot Numbers: 11088595
  • 11089104
  • 11089369
  • 11089370
  • 11094673
  • 11094679
  • 11095843
  • 11096115
  • 11098022
  • 11098023
  • 11098643
  • 11098707

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Argon Medical Devices, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Argon Medical Devices, Inc

See all →

Same hazard · sterility compromise

See all →