Medical device recalls Moderate risk

Teleflex Medical recalls Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife…

Recall date
September 26, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0039-2018
FDA classification
Class II
Brand / firm
Teleflex Medical
Sold / distributed
Worldwide Distribution: US (Nationwide) and countries of: Canada, France, Taiwan, Argentina, Australia, S. Korea, Belgium, Singapore, India, Indonesia, Philippines and Thailand.

Why it was recalled

The knife handles slot depth is out of specification, so blades may not fit on the handles properly.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.

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