Recall Z-2287-2018

Teleflex Medical Europe Ltd · initiated June 12, 2018

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

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

Codes / lots: Lot Numbers: F7, G7

Reason for recall

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

FDA-determined cause: Under Investigation by firm

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."

Details

Recall number
Z-2287-2018
Initiated
June 12, 2018
Posted by FDA
June 14, 2018
Terminated
April 2, 2021
Product code
LRW – Scissors, General, Surgical
Quantity
573 units
Distribution
Worldwide Distribution - US Nationwide and the countries of Canada, India
Recalling firm
Teleflex Medical Europe Ltd, Athlone

Official FDA recall record