| Date Initiated by Firm | April 03, 2017 |
|---|
| Create Date | December 07, 2017 |
|---|
| Recall Status1 |
Terminated 3 on June 17, 2019 |
| Recall Number | Z-0208-2018 |
|---|
| Recall Event ID |
76945 |
| Product Classification |
Mask, oxygen - Product Code BYG
|
| Product | Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pediatric size 2.5 catalog #8025001, 3) small adult size 3 catalog #8003001, 4) medium adult size 4 catalog #8004001 and 5) large adult size 5 catalog #8005001
Patent airway management. |
|---|
| Code Information |
Product Lots: 31402822 to 31610791 |
| FEI Number |
1000120301
|
Recalling Firm/
Manufacturer |
Intersurgical Inc
6757 Kinne St.
E. Syracuse
NY
13057
|
| For Additional Information Contact |
315-451-2900 |
|---|
Manufacturer Reason
for Recall | A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated. |
|---|
FDA Determined
Cause 2 | Nonconforming Material/Component |
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| Action | Intersurgical sent an Urgent Medical Device Recall Notice dated April 3rd, 2017, along with response forms to Customers. Customers were advised to immediately discontinue use and quarantine affected products. If affected products were further distributed, customers are advised to notify those individuals and advise them of the recall situation and have them return their outstanding stock to you. Customers with questions can call the IS Customer Service line at 800-828-9633 for a Return Authorization Number. Once customers receive the Return Authorization Number, please enter it in the space provided on the Recall Response Form. The completed Recall Response Form should be emailed to: Support@intersurgicalinc.com
For further questions, please call (315) 451-2900) |
|---|
| Quantity in Commerce | 144 cases / 20 units |
|---|
| Distribution | Worldwide Distribution - US Distribution to the states of : IL, KY, OH, NY & VA and to the countries of : Canada & Mexico |
|---|
| 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.
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