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Health product recall

Imbibe Bone Marrow Aspiration Needles (2014-12-05)

Starting date:
December 5, 2014
Posting date:
December 15, 2014
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-42881

Recalled Products

A) Imbibe Bone Marrow Aspiration Needle
B) Imbibe Bone Marrow Aspiration Needle (Fenestrated)

Reason

Manufacturer has become aware that there is the potential for a breach in the inner or outer packaging pouches for the products.

Affected products

A) Imbibe Bone Marrow Aspiration Needle

Lot or serial number

All lots.

Model or catalog number

2090-0027
2090-0028
2090-0029

Companies
Manufacturer
Orthovita Inc.,
45 Great Valley Parkway,
Malvern
19355
Pennsylvania
UNITED STATES

B) Imbibe Bone Marrow Aspiration Needle (Fenestrated)

Lot or serial number

All lots.

Model or catalog number

2090-0030

Companies
Manufacturer
Orthovita Inc.,
45 Great Valley Parkway,
Malvern
19355
Pennsylvania
UNITED STATES