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
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
out of specification