Z-2086-2019Class II
Rusch EasyCath Kit
Teleflex Medical / initiated 2019-07-01 / Terminated / root cause: manufacturing process
Teleflex Medical began a recall of Rusch EasyCath Kit on . FDA classified it as Class II and gives the reason as "Potential for product not to be sterile". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2086-2019
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Teleflex Medical
- Product
- Rusch EasyCath Kit
- Product code
- KOD Catheter, Urological
- Reason for recall
- Potential for product not to be sterile.
- Root cause tag
- manufacturing process
- FDA root cause
- Equipment maintenance
- Action
- Teleflex Medical notified customers on about 07/01/2019 via "Urgent Medical Device Recall Notification" letter. Distributors were instructed to: 1. Immediately discontinue distribution and quarantine any affected products. 2. Communicate this recall to any of your customers who have received product included within the scope of the recall using the provided customer letter. 3. Have the customers return any affected product to you, together with a completed Recall Acknowledgement Form, for consolidation and return to Teleflex Medical. 4. To return recalled products to Teleflex Medical, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. A customerservice representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Teleflex Medical. 5. Once you have completed returning all of the recalled products from your own inventory and collecting and consolidating all of the recalled products from your customers, please check the box on the enclosed Recall Acknowledgment Form that indicates that you have completed the recall and fax it to 1-855-419-8507, Attn: Customer Service, or email it to [email protected]. 6. If you and your customers 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]. Risk Managers were instructed to: 1. Immediately discontinue use and quarantine any affected products. 2. Complete and return the enclosed Recall Acknowledgement Form 3. Once the Recall Acknowledgement Form is received, instructions will be provided on how to return any affected product directly to your distributor. 4. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to your distributor. For questions, contact your local sales repr
- Quantity in commerce
- 3,700 devices
- Distribution
- Nationwide distribution to CA, FL, IL, NC, NJ, OH, OK, TX.
- Product codes and lots
- Catalog Number ECK120, Lot Number 74C1900304, Expiration Date 03/01/2022. Catalog Number ECK125, Lot Number 74B1901676, Expiration Date 06/01/2022.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2086-2019 | Class II | Terminated | Voluntary: Firm initiated |
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