FDA-Device2017-10-25Class II

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.

Teleflex Medical
Hazard

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

Sold states
Worldwide Distribution: US (Nationwide) and countries of: Canada, France, Taiwan, Argentina, Australia, S. Korea, Belgium, Singapore, India, Indonesia, Philippines and Thailand.
Affected count
6197 units
Manufactured in
2917 Weck Dr, Research Triangle Park, NC, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0039-2018

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