Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife h

FDA device recall Z-0039-2018 · posted 2017-10-16 · Completed

Recall details

Recalling firm

Teleflex Medical

Reason for recall

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

Action taken

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 document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document your receipt of this letter." If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

Root cause

Process control

Status

Completed

Product code

GDZ

Quantity affected

6197 units

Distribution

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

Date initiated

2014-09-26

Date posted

2017-10-16

Location

Research Triangle Park, NC