The Recall Desk
HighFDA (Devices)·Z-0820-2019·Announced 2019-02-13

Bone Marrow Biopsy Needle Recall Due to Sterile Seal Manufacturing Issue

Angiotech is recalling 504 bone marrow biopsy needles due to a manufacturing issue affecting the sterile seal on blister trays.

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 involves a medical device with a defect that compromises sterility, creating a risk of infection or harm, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Angiotech (Manan Medical Products, Inc.) is recalling 504 units of the Bone Marrow Biopsy Needle, Model Number UCIN-15-5, Lot Number LJ2T. The product is a manual surgical instrument used for bone marrow biopsy and aspiration.

The recall was initiated because the company identified an internal manufacturing issue regarding the formation of the sterile seal on some of the blister trays for this product line. This defect may compromise the sterility of the needles.

The affected units were distributed worldwide, including nationwide in the United States (specifically New Jersey) and in Mexico and South Korea. Healthcare facilities and users should stop using the affected needles and contact the recalling firm for further instructions.

The recalled product

Product
Aguja de Aspiration con Profundidad Ajustable Tipo I 15ga x 5 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
Manufacturer
Angiotech (Manan Medical Products, Inc.)
Category
Medical Device — Surgical Instruments
Hazard
Affected units
504

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 (2)

  • Model Number UCIN-15-5
  • Lot Number LJ2T

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 7 recalled by Angiotech (Manan Medical Products, 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 7 products in this recall →

Related recalls

Same manufacturer · Angiotech (Manan Medical Products, Inc.)

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Same hazard · sterility compromise

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