Recall Z-2287-2018
Teleflex Medical Europe Ltd · initiated June 12, 2018
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