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U.S. Department of Health and Human Services

Class 2 Device Recall PDS Plus Antibacterial monofilament syntheticabsorbable sutures

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  Class 2 Device Recall PDS Plus Antibacterial monofilament syntheticabsorbable sutures see related information
Date Initiated by Firm January 10, 2018
Create Date April 10, 2018
Recall Status1 Terminated 3 on April 11, 2019
Recall Number Z-1338-2018
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 CT-1 Needle
Code Information Product code: PDP346H GTIN: 10705031048126 Product lot: LL6459
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 7020
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.
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