|
Class 2 Device Recall Ethicon |
|
Date Initiated by Firm |
March 12, 2019 |
Create Date |
April 12, 2019 |
Recall Status1 |
Terminated 3 on July 17, 2020 |
Recall Number |
Z-1136-2019 |
Recall Event ID |
82420 |
Product Classification |
Suture, surgical, absorbable, polydioxanone - Product Code NEW
|
Product |
PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDS II suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable |
Code Information |
Lot Code: MGM110 |
Recalling Firm/ Manufacturer |
Ethicon, Inc. Us Highway 22 West Somerville NJ 08876
|
For Additional Information Contact |
SAME 908-218-0707
|
Manufacturer Reason for Recall |
VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.
|
FDA Determined Cause 2 |
Packaging process control |
Action |
Ethicon notified primary and secondary US consignees via UPS second day between March 12-15,2019. Receipt of the letter confirmed via UPS tracking. Ethicon Johnson & Johnson Affiliates in North America (Canada), Europe, Middle East. Latin America and Asia Pacific will notify their impacted consignees by providing the customer letter through post, email or sales representative visits.
The letter describes the problem and action to take:Examine your inventory immediately to determine if you have product subject to this recall (removal) on hand and quarantine such product(s). Remove the product subject to this voluntary recall (removal) and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. Do not open foil pouches to confirm contents. If any product subject to this recall (removal) has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall (removal) letter when communicating.
Customers are required to return unused impacted VICRYL Suture, VICRYL Plus Suture, PDS Suture and PDS Plus Suture Products subject to this recall (removal) that are in their inventory immediately. To receive replacement product, customers must return product subject to this recall (removal) by July 31, 2019. Questions regarding this recall (removal) or to report any customer complaints,contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266), Monday through Friday, 7:30 AM to 6:30 PM ET.
A Business Reply Form (BRF) asked to be completed and returned. |
Quantity in Commerce |
550,681 eaches (WW) Total |
Distribution |
Worldwide distributions - US Nationwide and countries of
AUSTRALIA
BELGIUM
CANADA
CHINA
ISRAEL
JAPAN
PUERTO RICO
SINGAPORE |
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.
|
|
|
|