REUSABLE STRIPPER/CLEAVER FIBERS (2015-06-19)

Starting date:

June 19, 2015

Posting date:

July 29, 2015

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-54436

• Reason
• Affected products

Affected Products

A.SUREFLEX LITHOTRIPSY FIBER - REUSABLE

B.Fiber Stripper, 150um, autoclavable

C.Fiber Stripper, 200um, autoclavable

D.Fiber Stripper, 273um, autoclavable

E.Fiber Stripper, 365um, autoclavable

F.Fiber Stripper, 550um, autoclavable

G.Fiber Stripper, 910um, autoclavable

H.Fiber Cleaver

I.1X1 Cleaving Tiles

J.Tool, Stripper w/bld, 10s, nonautoclavable

K.Tool, Stripper w/bld, 10s, autoclavable

L.Tool, Stripper w/bld, 12s, nonautoclavable

M.Tool, Stripper w/bld, 12s, autoclavable

N.Tool, Stripper w/bld, 14s, nonautoclavable

O.Tool, Stripper w/bld, 14s, autoclavable

P.Tool, Stripper w/bld, 18s, nonautoclavable

Q.Tool, Stripper w/bld, 18s, autoclavable

R.Tool, Stripper w/bld, 44s, nonautoclavable

S.Tool, Stripper w/bld, 44s, autoclavable

T.Tool, Stripper w/bld, 28s, nonautoclavable

U.Tool, Stripper w/bld, 28s, autoclavable

V.Stripper, 0.6mm disposable endostat fiber

W.Stripper, 0.4mm disposable endostat fiber

X.Stripper, 0.3mm disposable endostat fiber

Y.Stripper, 0.2mm disposable endostat fiber

Reason

Validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use for the reusable stripper and cleaver accessories do not meet the new guidance on qualifying reusable products.

Affected products