Date Initiated by Firm |
January 10, 2018 |
Create Date |
April 10, 2018 |
Recall Status1 |
Terminated 3 on April 11, 2019 |
Recall Number |
Z-1340-2018 |
Recall Event ID |
79541 |
510(K)Number |
K061037
|
Product Classification |
Suture, surgical, absorbable, polydioxanone - Product Code NEW
|
Product |
PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle |
Code Information |
Product code: PDPB346 GTIN: 10705031048829 Product lot: LMM273 |
Recalling Firm/ Manufacturer |
Ethicon, Inc. Us Highway 22 West Somerville NJ 08876
|
For Additional Information Contact |
908-218-0707
|
Manufacturer Reason for Recall |
Three (3) lots were distributed with the incorrect expiry date on the label. The lots
were labeled with an expiry date of five (5) years from date of manufacture instead
of the correct expiry date of two (2) years from date of manufacture.
|
FDA Determined Cause 2 |
Process control |
Action |
On January 10, 2018 an URGENT MEDICAL DEVICE LETTER for removal was issued to customers requesting that all affected personnel to discontinue use or distribution of the recalled product. The following actions being required:
1. Examine inventory and quarantine all affected product
2. Communicate this recall notice to all affected personnel at facility, or other affected facilities.
3. Complete the business reply form attached to the recall letter.
4. Keep the recall notice posted visibly at facility and maintain a copy with your records
5. Return unused product to recalling firm by April 13, 2018.
For further assistance contact 1-855-215-5039. |
Quantity in Commerce |
180 |
Distribution |
Distribution US Nationwide, Canada, India, and Colombia. |
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 = NEW and Original Applicant = ETHICON, INC.
|