| Class 2 Device Recall Pilling(R) UNIVERSAL SHEARS |  |
Date Initiated by Firm | June 12, 2018 |
Date Posted | June 14, 2018 |
Recall Status1 |
Terminated 3 on April 02, 2021 |
Recall Number | Z-2287-2018 |
Recall Event ID |
80279 |
Product Classification |
Scissors, general, surgical - Product Code LRW
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Product | Teleflex 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 |
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 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 Commerce | 573 units |
Distribution | Worldwide Distribution - US Nationwide and the countries of Canada, India |
Total Product Life Cycle | TPLC Device Report |
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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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