ClearanceBrief
Recall Z-2287-2018 ยท LRW Scissors, General, Surgical

Teleflex Medical Europe Ltd

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

DateJun 14, 2018 (initiated Jun 12, 2018)
StatusTerminated
ReasonThe incorrect plastic was used to manufacture the handles of these shears, which causes the handles to melt if sterilized.
Root causeUnder Investigation by firm
ActionThe 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)
Quantity573 units
DistributionWorldwide Distribution - US Nationwide and the countries of Canada, India
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.