Recall record at a glance
| Official record | Z-0039-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Completed |
| Recalling firm | Teleflex Medical |
| Report date | Oct 25, 2017 |
| Recall initiation date | Sep 26, 2014 |
| Quantity | 6197 units |
| Location | Research Triangle Park, NC, United States |
Official product description
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.
Why the product was recalled
The knife handles slot depth is out of specification, so blades may not fit on the handles properly.
Distribution information
Worldwide Distribution: US (Nationwide) and countries of: Canada, France, Taiwan, Argentina, Australia, S. Korea, Belgium, Singapore, India, Indonesia, Philippines and Thailand.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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