| Date Initiated by Firm | January 23, 2017 |
|---|
| Create Date | March 04, 2017 |
|---|
| Recall Status1 |
Terminated 3 on August 07, 2019 |
| Recall Number | Z-1409-2017 |
|---|
| Recall Event ID |
76327 |
| 510(K)Number | K041501 |
|---|
| Product Classification |
Cover, barrier, protective - Product Code MMP
|
| Product | Premier Guard Drape, Sterile.
For Use with Verisphere (01-0035) and ArQ.Sphere (01-0044)
Item Number: 01-0037
Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures |
|---|
| Code Information |
Lot Numbers: 1410577-4 to 1605778 |
Recalling Firm/
Manufacturer |
Covidien LLC
60 Middletown Ave
North Haven CT 06473-3908
|
| For Additional Information Contact | SAME
203-492-5000 |
|---|
Manufacturer Reason
for Recall | Sterility compromised due to breach in sterile barrier |
|---|
FDA Determined
Cause 2 | Packaging process control |
|---|
| Action | Medtronic issued recall letter on January 23, 2017. Customers were notified via Federal Express and the letter instructed customers to discontinue use of the product and return all inventory to Medtronic (Covidien) 195 McDermott Road, North Haven, CT 06473 Attn: Field Returns Department. |
|---|
| Quantity in Commerce | 42,750 units |
|---|
| Distribution | Nationwide |
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = MMP
|
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