Medical Device Recall: Z-0039-2018

FDA Recalls dataset · Firm: Teleflex Medical · Status: Completed

Recall Action Class: N/A Date Initiated: 2014-09-26 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0039-2018.

Recall Res Number
Z-0039-2018
Recalling Firm / Manufacturer
Teleflex Medical
FEI Number
3005747797
Recall Status
Completed
Recall Classification
N/A
Date Initiated
2014-09-26
Date Posted
2017-10-16
Date Terminated
N/A
Product Code
GDZ
Event Number
78207
Product Quantity
6197 units
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.
Reason for Recall The knife handles slot depth is out of specification, so blades may not fit on the handles properly.
Action Details 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.
Distribution Pattern Worldwide Distribution: US (Nationwide) and countries of: Canada, France, Taiwan, Argentina, Australia, S. Korea, Belgium, Singapore, India, Indonesia, Philippines and Thailand.
Code Information / Serial Numbers 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

Related Establishments / Registrations

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