Teleflex Percuaneous Solutions, Johans Grasper, Ref ML004EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park, N
FDA device recall Z-0059-2017 · posted 2016-10-07 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- Reason for recall
- The product is being recalled due to a labeling error. The Gripper Graspers are labeled as Johans Graspers and the Johans Graspers are labeled as Gripper Graspers.
- Action taken
- The firm, Teleflex Medical, sent an "Urgent Medical Device Recall Notification" Letter dated 9/9/2016 to consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use and quarantine any products listed; 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 even if you do not have the affected product. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 160 ea. in total
- Distribution
- US Distribution to states of: AZ, CA, FL, NY, NC, and TX.
- Date initiated
- 2016-09-09
- Date posted
- 2016-10-07
- Date terminated
- 2017-08-25
- Location
- Research Triangle Park, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Percuvance(R) Percutaneous Surgical System (K143299) | Teleflexmedical, Inc. | 2015-01-21 |