Z-2558-2016Class II
Valleylab Laparoscopic Argon Modified Flat l Electrode 28CM Item Code: E258128 The Valleylab Laparoscopic...
Medtronic, Inc. / initiated 2016-07-08 / Terminated / root cause: manufacturing process
Medtronic began a recall of Valleylab Laparoscopic Argon Modified Flat l Electrode 28CM Item Code: E258128 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in... on . FDA classified it as Class II and gives the reason as "Potential for compromise of the package resulting in a breach of the sterile barrier". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2558-2016
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Medtronic, Inc.
- Product
- Valleylab Laparoscopic Argon Modified Flat l Electrode 28CM Item Code: E258128 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
- Product code
- GEI Electrosurgical, Cutting & Coagulation & Accessories
- Reason for recall
- Potential for compromise of the package resulting in a breach of the sterile barrier
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- Medtronic/Covidien sent an Urgent Medical Device Recall letter dated July 8, 2016, to all affected customers via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. The letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Customers with questions were instructed to contact their Medtronic representative or Customer Service at 800-882-5878.
- Quantity in commerce
- 3530
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
- Product codes and lots
- Affected Lot Range: 211742X through 60870082X
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2554-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2555-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2556-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2557-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2558-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2559-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2560-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2561-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2562-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2563-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2564-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2565-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2566-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2567-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2568-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2569-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2570-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2571-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2572-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2573-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2574-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2575-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2576-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2577-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2578-2016 | Class II | Terminated | Voluntary: Firm initiated |
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