Recall Z-0039-2018 ยท GDZ Handle, Scalpel
Teleflex Medical
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.
| Date | Oct 16, 2017 (initiated Sep 26, 2014) |
| Status | Completed |
| Reason | The knife handles slot depth is out of specification, so blades may not fit on the handles properly. |
| Root cause | Process control |
| Action | The firm, Teleflex, sent an "Urgent Medical Device Recall 1st Notification" letter dated 09/26/2017 to its customers by FedEx 2-day. The letter described the product, problem and actions to be taken. All affected consignees are instructed to take the following actions: "1. If you have affected stock, immediately discontinue use and quarantine any products with the product codes and lot numbers listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to docum |
| Quantity | 6197 units |
| Distribution | Worldwide Distribution: US (Nationwide) and countries of: Canada, France, Taiwan, Argentina, Australia, S. Korea, Belgium, Singapore, India, Indonesia, Philippines and Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.