Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable) Ref 3222
FDA device recall Z-1987-2014 · posted 2014-07-02 · Terminated
Recall details
- Recalling firm
- Microline Surgical, Inc.
- Reason for recall
- Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw
- Action taken
- Microline Surgical notified Distributors, Hospitals (Customers/End Users) and Suppliers via letter dated May 15, 2014 with labeling, pictures, and Recall Response Forms via UPS Overnight Air, email, and/or fax. Product is requested to be returned and a RMA number will be issued. Contact 978-867-1775 for questions.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 6290 units
- Distribution
- Worldwide Distribution-USA including the states of CA, HI, ID, MA, MI, MS, PA, TN, UT, and TX. and the countries of Belgium, France, Ireland, Germany, Indonesia, Korea, Norway, Saudi Arabia, Switzerla
- Date initiated
- 2014-05-12
- Date posted
- 2014-07-02
- Date terminated
- 2015-08-13
- Location
- Beverly, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DISPOSABLE RE-NEW FORCEPS (K981389) | Microline Pentax, Inc. | 1998-05-29 |