Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2287-2018Class II

Teleflex MEDICAL Pilling(R) UNIVERSAL SHEARS 7 1/2", REF 142542

Teleflex Medical / initiated 2018-06-12 / Terminated / root cause: sterility

Teleflex Medical Europe Ltd began a recall of Teleflex MEDICAL Pilling(R) UNIVERSAL SHEARS 7 1/2", REF 142542 Product Usage: general surgical scissors on . FDA classified it as Class II and gives the reason as "The incorrect plastic was used to manufacture the handles of these shears, which causes the handles to melt if sterilized". As of , the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number
Z-2287-2018
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Teleflex Medical
Product
Teleflex MEDICAL Pilling(R) UNIVERSAL SHEARS 7 1/2", REF 142542 Product Usage: general surgical scissors
Product code
LRW Scissors, General, Surgical
Reason for recall
The incorrect plastic was used to manufacture the handles of these shears, which causes the handles to melt if sterilized.
Root cause tag
sterility
FDA root cause
Under Investigation by firm
Action
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 [email protected]. 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 [email protected]. This will allow us to document your receipt of this letter."
Quantity in commerce
573 units
Distribution
Worldwide Distribution - US Nationwide and the countries of Canada, India
Product codes and lots
Lot Numbers: F7, G7

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2287-2018
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2287-2018Class IITerminatedVoluntary: Firm initiated