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U.S. Department of Health and Human Services

Class 2 Device Recall Pilling(R) UNIVERSAL SHEARS

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 Class 2 Device Recall Pilling(R) UNIVERSAL SHEARSsee related information
Date Initiated by FirmJune 12, 2018
Date PostedJune 14, 2018
Recall Status1 Terminated 3 on April 02, 2021
Recall NumberZ-2287-2018
Recall Event ID 80279
Product Classification Scissors, general, surgical - Product Code LRW
ProductTeleflex MEDICAL Pilling(R) UNIVERSAL SHEARS 7 1/2", REF 142542 Product Usage: general surgical scissors
Code Information Lot Numbers: F7, G7
Recalling Firm/
Manufacturer		 Teleflex Medical Europe Ltd
Ida Business Park
Athlone Ireland
Manufacturer 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 2		Under 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) 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."
Quantity in Commerce573 units
DistributionWorldwide Distribution - US Nationwide and the countries of Canada, India
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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