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Recall Observatory FDA recall evidence

Device product

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.

Z-0039-2018

September 26, 2014

Class II

Product summary

Firm
Teleflex Medical
Event
Event 78207
Status
Completed
Classification
Class II
Quantity
6197 units
Official record key
device-enforcement:Z-0039-2018

Official wording

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

Code information: a) REF 352950: Lot numbers: D6, J6, E6, F6, G6, H6, I6 b) REF 352953: Lot numbers: I6, B6, E6 c) REF 352951: Lot numbers: I6, J6 d) REF 352957: Lot numbers: A6, B6, B7, K6, L6 e) REF 352952: Lot numbers: H6

Distribution pattern: Worldwide Distribution: US (Nationwide) and countries of: Canada, France, Taiwan, Argentina, Australia, S. Korea, Belgium, Singapore, India, Indonesia, Philippines and Thailand.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification