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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2287-2018 | Class II | Terminated | Voluntary: Firm initiated |
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