Agency classClass IIOur severity:High FDA (Devices)·Z-1194-2017·Announced 2017-02-22

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 involves a risk-of-harm product (sterility compromise in a medical device) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Argon Medical Devices, Inc. is recalling 497 boxes of Bone Marrow Aspiration Needles (15G x 2.688 MAX and 15G x 4 MAX). The recall involves lots 11156986, 11158618, and 11158620. These products were distributed nationwide in the United States and internationally to Switzerland, Canada, Australia, New Zealand, Ecuador, Colombia, and Japan.

The recall was initiated after the firm received a customer complaint regarding a potential defect in the forming of the primary blister package. This defect may compromise the sterility of the product inside the tray. The needles are intended for the purpose of harvesting bone and/or bone marrow specimens.

Healthcare facilities and distributors should stop using the affected products and contact Argon Medical Devices for further instructions. Consumers should not use these medical devices if they have them in their possession.

The recalled product

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
Manufacturer: Argon Medical Devices, Inc
Category: Medical Device — Surgical Instruments
Hazard: sterility-compromise
packaging-defect
Affected units: 497

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 (3)

lots: 11156986
11158618
11158620

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Same manufacturer · Argon Medical Devices, Inc

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