Teleflex MEDICAL Pilling(R) UNIVERSAL SHEARS 7 1/2", REF 142542 Product Usage: general surgical scissors

FDA device recall Z-2287-2018 · posted 2018-06-14 · Terminated

Recall details

Recalling firm

Teleflex Medical Europe Ltd

Reason for recall

The incorrect plastic was used to manufacture the handles of these shears, which causes the handles to melt if sterilized.

Action taken

The firm initiated the recall by letter on 06/12/2018. 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 code 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."

Root cause

Under Investigation by firm

Status

Terminated

Product code

LRW

Quantity affected

573 units

Distribution

Worldwide Distribution - US Nationwide and the countries of Canada, India

Date initiated

2018-06-12

Date posted

2018-06-14

Date terminated

2021-04-02

Location

Athlone, Ireland