The Recall Desk
HighFDA (Devices)·Z-0816-2019·Announced 2019-02-13

Angiotech Recalls Bone Marrow Needles Due to Sterile Seal Manufacturing Issue

Angiotech is recalling 180 units of J Type Bone Marrow 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 in the sterile seal, which poses a risk of harm (infection) even though no injuries are reported in the source text. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Angiotech (Manan Medical Products, Inc.) is recalling 180 units of J Type Bone Marrow Needles (13ga x 6cm). The recall involves Model Number IMKBMN-13R-6, Lot Number LFD9. These manual surgical instruments are 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 the Bone Marrow Biopsy Needle product line.

The affected products were distributed worldwide, including nationwide in the United States (specifically New Jersey) and in Mexico and South Korea. The source text does not specify instructions for consumers or healthcare providers regarding the handling of these units.

The recalled product

Product
J Type Bone Marrow Needle 13ga x 6cm - 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
180

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 IMKBMN-13R-6
  • Lot Number LFD9

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 · sterile seal defect

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